Castor Launches Scalable Decentralized Trial Platform After 383% Commercial Growth

December 17th, 2020 by

Hoboken, New Jersey: December 17, 2020: Castor, a leading provider of clinical trial technology, today announced the launch of its scalable end-to-end decentralized clinical trial (DCT) platform.

With this launch, Castor is meeting the increasing demand in the market for technology that makes trials more patient centric and enables a hybrid approach (in-home or site-based) to trial visits, which has been accelerated by the pandemic. The platform includes modules to support remote enrollment, remote eConsent, native patient-facing apps, a complete EDC, and integrated real-time reporting capabilities. 

On launching the DCT platform, Castor CEO Derk Arts, MD, PhD, said: “Castor has always had a strong focus on patient-centric and technology-enabled trials, as I believe these trials will become the reference standard for the life sciences industry. In the past nine months we focused our product development on creating a platform that makes these trials scalable, as we see an enormous bottleneck in the industry on launching these technologically challenging trials in acceptable timelines.”

The launch comes on the back of a high impact year for Castor, in which they supported the World Health Organization with their landmark Solidarity trials on COVID vaccines and treatments, and supported more than 300 COVID-related trials pro bono. In the second half of the year, commercial growth was 383% compared to the same period in 2019. A major commercial milestone was winning a contract for multiple cross-country eConsent projects with a top 10 pharma company.

Castor will be working closely with the recently launched Decentralized Trials & Research Alliance (DTRA) as one of the founding members to ensure the successful adoption of this technology.

Craig Lipset, DTRA Co-Convener and Castor Advisory Board member, said: “The pandemic has catalyzed the adoption of decentralized clinical trials, and sponsors are increasingly making it clear that there is no going back. While many embraced flexible participation as a necessity for business continuity, they are committing to these approaches to improve patient access, experience, and diversity.”

Castor’s key achievements in 2020 include:

About Castor 

Based in the United States and The Netherlands, Castor is an international health-tech company founded by CEO Derk Arts, MD, PhD. Their cloud-based clinical data platform simplifies the clinical trial process, from recruitment to analysis, for researchers worldwide.

More than 65,000 researchers across 90 countries are using Castor to supercharge their research. Castor’s platform has supported more than 4,000 commercial and academic studies that cover a broad range of therapeutic areas including diabetes, cardiovascular disease, rare diseases, infectious diseases, and oncology. Researchers on the platform generate vast amounts of data from traditional and remote trials, and Castor recently reached milestones of 250,000,000 data points and 2,200,000 enrolled patients. Castor’s goal is to make the world’s research data reusable, enabling AI-driven clinical trials, and ultimately creating a future in which they maximize the impact of data through reuse.

In 2020, Castor raised a $12M Series A from Two Sigma Ventures with participation from Hambrecht Ducera Growth Ventures and existing investor INKEF Capital. Castor previously raised a $6.25M seed round from INKEF Capital in 2018.

LinkedIn: www.linkedin.com/company/ciwit-b-v-
Twitter: www.twitter.com/castor

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Castor Expands Advisory Board to Support US Growth of Decentralized Clinical Trial Platform

December 8th, 2020 by

Industry veterans from leading life sciences companies including Johnson & Johnson, Biogen, and Medtronic, will support the Company’s vision to advance the future of clinical research 

Hoboken, New Jersey: December 8, 2020: Castor, a leading provider of clinical trial technology that automates the research process, today announced the expansion of its independent Advisory Board. 

Castor is a leading cloud-based clinical data platform that simplifies the clinical trial process, from recruitment to analysis, for researchers globally. It’s used by more than 65,000 users across academia and commercial research, powering more than 4,000 studies with more than 2,200,000 enrolled patients across 90 countries. 204 medical device, biotech, and pharmaceutical companies and contract research organizations (CROs) are using Castor’s platform.

Over the past year, Castor’s Advisory Board has been instrumental in helping the company navigate the pandemic and support COVID-19 research around the world. This includes the World Health Organization’s Solidarity Trial. The Advisory Board also played a key role during the development and launch of the company’s new remote recruitment, screening, and consent solution, Castor eConsent. 

Castor has continuously looked for additional industry veterans to expand the Advisory Board and have been fortunate to secure Sarah F. Fisher, Cherié L. Butts, PhD, and Janine Lane. These individuals bring tremendous expertise across commercial life sciences research and innovation, currently holding leadership positions at Johnson & Johnson, Biogen, and Medtronic. They will provide invaluable guidance to help the company achieve its vision to make the world’s research data reusable, enabling AI-driven clinical trials, and ultimately creating a future in which they maximize the impact of data through reuse. 

On welcoming the members, Castor CEO Derk Arts, MD, PhD, said: “With COVID-19 propelling decentralized trials due to necessity, we need to continue this momentum beyond the pandemic and work together as an industry to advance clinical trial technology and practices. With our expanded Advisory Board and continuous innovation in our technology, Castor is ready to power global decentralized and hybrid clinical trials for years to come.”

Cherie Butts, PhDCherié L. Butts, PhD, Medical Director and Head of Clinical Assessments at Biogen and newly appointed Castor Advisory Board member, commented: “I am excited to serve on Castor’s Advisory Board and work with the team on better ways to leverage academic and industry research. Castor’s decentralized trial technology makes it easier for patients to participate in clinical trials, and to remain engaged. Furthermore, Castor’s vision for machine readable, reusable research data across studies will help ensure all captured patient data has maximum impact.”

The new Advisory Board members include:

Sarah, Cherié, and Janine will join the following current Advisory Board members:

 For full biographies please see below.


About Castor 

Based in the United States and The Netherlands, Castor is an international health-tech company founded by CEO Derk Arts, MD, PhD. Their cloud-based clinical data platform simplifies the clinical trial process, from recruitment to analysis, for researchers worldwide.

More than 65,000 researchers across 90 countries are using Castor to supercharge their research. Castor’s platform has supported more than 4,000 commercial and academic studies that cover a broad range of therapeutic areas including diabetes, cardiovascular disease, rare diseases, infectious diseases, and oncology. Researchers on the platform generate vast amounts of data from traditional and remote trials, and Castor recently reached milestones of 250,000,000 data points and 2,200,000 enrolled patients. Castor’s goal is to make the world’s research data reusable, enabling AI-driven clinical trials, and ultimately creating a future in which they maximize the impact of data through reuse.

In 2020, Castor raised a $12M Series A from Two Sigma Ventures with participation from Hambrecht Ducera Growth Ventures and existing investor INKEF Capital. Castor previously raised a $6.25M seed round from INKEF Capital in 2018.

Castor Advisory Board 

Sarah F. Fisher, MBA

Sarah F. Fisher is the Global Health Financing Lead at Johnson & Johnson.  She has 18 years of experience in leading new business development efforts across a breadth of healthcare areas in global markets including: MedTech (class III, novel, PMA), Drug/Device combination technologies and services, Informatics and Digital, Disease Prevention and Interception, Supply Chain and Operations, Real World Data Platforms, Strategic Partnerships, Public Health, and Venture Diligence.

Sarah serves as venture partner to select investors, an advisory board member to select ventures, and as the healthcare subgroup lead for the International Venture Club based in the EU. She was awarded the first-ever Corporate Entrepreneur accolade by Corporate Entrepreneurs, LLC, and was named a Global Corporate Venturing Rising Star in 2016.

Sarah has a Masters of Business Administration in Entrepreneurship from Babson College in Wellesley, MA and a post -graduate diploma in Global Business from the University of Oxford in Oxford, UK.

Cherié L. Butts, PhD

Cherié L. Butts is the Medical Director and Head of Clinical Assessments – Digital & Quantitative Medicine at Biogen. She obtained undergraduate and graduate degrees from The Johns Hopkins University, a doctorate from the University of Texas MD Anderson Cancer Center, and completed a postdoctoral fellowship at the National Institutes of Health. She continued research at the US Food & Drug Administration, taking on additional responsibilities of evaluating drug and biologics applications.  At Biogen, she is responsible for use of novel clinical measurement tools as a mechanism for better understanding disease biology, reducing trial burden, and ensuring trials better represent those afflicted with disease. 

Cherié is passionate about connecting the work in academia, government, and industry to advance biomedical research and works with scientific professional societies and related organizations to help scientists and clinicians learn about the interconnectedness of scientific contributions across these sectors – at and away from the bench or clinic. She currently serves on the Leadership Board of Beth Israel Deaconess Medical Center; Board of Directors of Keystone Symposia; Vice Chair on the Board of Trustees at Salem State University; Council of the Society of Leukocyte Biology; and is Adjunct Professor at University of Maryland.   

Janine Lane 

Janine Lane is the Senior Director of Medical Affairs at Medtronic with her current focus being interventional cardiology and hypertension. In this global role she and her team are responsible for scientific and clinical communication for both Medtronic sponsored and physician initiated clinical studies, engagement with a broad array of physicians and institutions to encourage informed clinical decision making leveraging existing data.

With experience in the clinical world for over 35 years and at Medtronic for almost 30 years, Janine has seen how the practice of medicine can be transformed with access to credible data with many patient lives changed in positive ways. She has also experienced the impact of the absence of evidence in a timely fashion leading to confusion, waste and poor outcomes.

Janine started her clinical and corporate career in Australia before moving to the United States in 1996 where she worked closely on FDA interactions, including panel meetings, influencing clinical trial design and data acquisition approaches for Medtronic. Janine has also partnered with an array of thought leaders in the field of interventional cardiology and more recently the management of hypertension.

Craig Lipset, MBA

Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement. 

Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). During that time, Craig designed and launched multiple industry firsts. He currently serves on the Board of Directors for the Foundation for Sarcoidosis Research, the MedStar Health Research Institute, and the People-Centered Research Foundation (the central office for PCORnet), as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science.

Niels van Royen, MD, PhD

Niels van Royen studied medicine at the University of Amsterdam and received his doctorate degree in 1998. In 2003 he obtained – with honors – his PhD on research in collateral artery. The research was conducted in collaboration with the Max-Planck Institute in Bad Nauheim and the University of Freiburg. 

Niels specialized in Cardiology in AMC Amsterdam (2003-2008). In 2010 he started as a cardiologist at the VU Medical Center. In 2012 he was appointed as Professor of Intervention Cardiology. Here he has set up translational research lines focusing on repair in ischemic heart diseases.

Thomas Wurdinger, PhD

Thomas Wurdinger studied molecular biology at VU University in Amsterdam and performed his PhD at Utrecht University. After his postdoc period at Harvard Medical School and Massachusetts General Hospital he now holds a position as Director of the Neuro-Oncology Research Group and Professor at the Amsterdam UMC Cancer Center. 

Thomas’ mission is to eliminate late-stage cancers, including brain cancer. His passion for research goes hand in hand with an ambition for entrepreneurship applied to a field with societal importance, e.g. by capturing sequencing data and designing deep learning algorithms to detect cancer from a tube of blood. He strives to translate academic research into clinical applications. This is why he founded two biotech companies, with thromboDx focusing on blood platelet-based diagnostics (acquired by Illumina), and the second being Exbiome BV, which sets out to use microRNAs for diagnostic purposes. Thomas was also one of the first directors of research at GRAIL Inc, a unicorn company aiming to detect cancer early when it can be cured. He is a recipient of the Galenus Research Award and several ERC grants.

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Castor Raises a $12M Series A to Further Their Support for COVID-19 Research

August 19th, 2020 by

With 4,000 live studies and 2M enrolled patients across 90 countries, Castor will use the funding to further invest in enabling patient-centric, data-powered clinical trials.


Hoboken, New Jersey: August 19, 2020: Castor, a leading provider of clinical trial technology that automates the research process, today announced that it has raised $12 million in funding. The round was led by Two Sigma Ventures with participation from Hambrecht Ducera Growth Ventures and existing investor INKEF Capital.

Castor is a leading cloud-based clinical data platform that simplifies the clinical trial process, from recruitment to analysis, for researchers globally. It’s used by more than 50,000 users across academia and commercial research, powering more than 4,000 studies with more than 2,000,000 enrolled patients across 90 countries. 192 medical device, biotech, and pharmaceutical companies and contract research organizations (CROs) are using Castor’s platform.

Castor made its platform freely available for all non-profit COVID-19 research starting in February. They are one of the only providers that can enable large-scale decentralized trials to accelerate the work of researchers who are trying to combat the disease. More than 200 COVID-19 projects across 33 countries are currently running on the platform, including the World Health Organization’s global Solidarity trial. Through their platform, more than 10,000,000 COVID-19 data points have been captured and 50 COVID-19 projects have committed to making their data reusable and accessible to others, so that the world can collaborate effectively to stop the disease.

Castor vs. COVID19 Coronavirus“There are three key challenges that need to be addressed in the clinical trial space: making research more patient-centric, maximizing the impact of data on human lives, and better addressing the needs of underserved communities,” said Derk Arts, MD, PhD, CEO & Founder of Castor. “With this new investment, we will be able to make significant progress in all three areas by continuing to deliver user-friendly, accessible technology that can support remote trials, while ensuring machine-readable output that allows for trial automation and data reuse. In the next 18 months we intend to support our customers with patient recruitment and synthetic control arms, through better use of their data. We are excited to partner with Two Sigma Ventures, who bring extensive experience in leveraging the power of data and AI to disrupt incumbent industries.”

Castor will use this new funding to further strengthen its support for patient-centric, remote trials and to enable customers to maximize value from existing and newly generated data throughout the clinical trial process. 

“We believe that the life sciences industry is lacking a comprehensive and scalable solution for recruiting candidates for clinical trials, managing the research process, and effectively harnessing the vast amounts of data those clinical trials produce to drive medical breakthroughs,” said Villi Iltchev, Partner at Two Sigma Ventures. “Castor’s technology and team have the ability to meet all of those needs as evidenced by their customer demand and ability to enter new segments. It is our belief that their vision to enable AI and automation in clinical trials will quickly change the face of clinical research.”

About Castor 

Based in the United States and The Netherlands, Castor is an international health-tech company founded by CEO Derk Arts, MD, PhD. Their cloud-based clinical data platform simplifies the clinical trial process, from recruitment to analysis, for researchers worldwide.

More than 50,000 researchers across 90 countries are using Castor to supercharge their research. Castor’s platform has supported more than 4,000 commercial and academic studies that cover a broad range of therapeutic areas including diabetes, cardiovascular disease, rare diseases, infectious diseases, and oncology. Researchers on the platform generate vast amounts of data from traditional and remote trials, and Castor recently reached milestones of 180,000,000 data points and 2,000,000 enrolled patients. Castor’s goal is to make the world’s research data reusable, enabling AI-driven clinical trials, and ultimately creating a future in which they maximize the impact of data through reuse.

In 2018, Castor raised $6.25M from early-stage investor INKEF Capital in Europe.

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Joel White’s Q4 CRO breakdown: strong bookings, a sell-off that didn’t match, and the disruption gap nobody is talking about

April 9th, 2026 by

Event summary
March 18, 2026
5 min read

CRO bookings were up year over year and accelerating. Revenues were recovering across most major players. Delays and cancellations, after a brutal stretch through much of 2025, had moved back to something closer to normal. So why did the stocks take a beating?

That disconnect was the starting point for a forty-five-minute conversation between Joel White, founder and principal at Market Capital Consulting, and Derk Arts, CEO at Castor. Joel spent fifteen years in-house at large and mid-sized CROs before founding his own practice, where he produces the quarterly market analysis that strategy and commercial teams across the sector use to benchmark pricing and track industry performance. His Q4 recap had landed the week before — twenty to thirty pages covering every major public CRO, drug discovery platform, and biopharma equity in the sector. The session was the annotated, live version. For clinical trial technology teams navigating AI-heavy market headlines, the session addressed a question with a specific and useful answer: where is the disruption actually landing, and where is it still narrative?

The clearest finding was that the AI-pocalypse narrative hit CRO stocks not because the numbers were bad, but largely because of how some companies handled questions about it. Bookings are up year over year and accelerating. Revenues are recovering across most of the major players.

Then came the analyst questions about AI strategy. Joel described the Medpace earnings call as a turning point for sentiment. Medpace is the sector’s highest-valuation outlier, significantly smaller than an IQVIA or ICON but priced for future growth. The CEO’s response to questions about AI did not land well. The stock was, in Joel’s words, “absolutely smashed. And still to this day, very depressed.” Contrast that with IQVIA and Fortrea, whose leadership arrived prepared with structured responses that, while not resolving the underlying concern, at least prevented things from getting worse.

“When it comes to some of the doomsday scenarios, for me, I need to start seeing that growth curve somehow reverse when other things are looking good.”

Joel White, Market Capital Consulting — follow Joel’s newsletter on LinkedIn

But the session drew a clear line between two different industries. For CROs running biotech clinical trials, nothing in the Q4 earnings data yet supports the disruption thesis. Joel’s argument runs on basic economic logic: if AI lowers the cost of drug development, more drugs get developed and more trials follow. He put it directly: “I tend to believe that clinical research…is very elastic to the extent that if the cost of development goes down, there will be more things that get developed, that there will be more trials to help de-risk the developments that are already in place.” The structure of CRO contracts reinforces this. Because the overwhelming majority run on fixed-price milestones rather than hourly billing, CROs have a direct financial incentive to adopt efficiency tools regardless of whether sponsors mandate them.

For drug discovery software companies, the picture looks different. Certara, Simulations Plus, and Evotec are at or near all-time lows, with companies explicitly citing seat-based license losses as a primary driver. IQVIA agreed to acquire Charles River’s preclinical platform earlier this year at a price that drew comment in the market for how low it came in. The signal is clear: AI disruption is already visible in drug discovery software. It has not yet appeared in CRO services data.

The session also surfaced a question worth sitting with: when do efficiency gains from decentralized trial models and electronic source integration start showing up as pricing pressure on CROs? Joel’s view was measured. The technology gains are real. But the contract structures, the pace of regulatory adoption, and the gap between trial efficiency and billing models suggest the impact is years away, not quarters.

Derk put the position of regulated electronic data capture and clinical operations software on the disruption timeline directly:

“The type of software that Castor and all of our friends in the space create is going to be the last to go because it’s heavily regulated. It’s the last thing you want to vibe code, basically.”

Derk Arts, CEO at Castor

For clinical trial teams building on regulated platforms, the practical takeaway is worth sitting with. The same compliance requirements that slow AI adoption in this space also make the underlying software category more stable. Procurement cycles, validation requirements, and regulatory audit trails don’t move at the pace of a general-purpose AI tool.

The recording covers considerably more than this post captures.

Joel runs through each major public CRO company in detail, including what ICON’s simultaneous accounting investigation announcement meant for investor confidence and why the Medpace CEO’s response carried such outsized consequences. He and Derk get into the drug discovery software sector at length, covering why some of these companies are moving to bring their own drug assets in-house and what that shift might mean for the traditional service model.

There is a specific exchange about whether new trial starts built on more modern decentralized clinical trial technology stacks will look materially different, and what Joel would need to see in the numbers to genuinely change his view on the disruption timeline.

Joel followed up the session with a post-event newsletter piece that takes the CRO-as-investor angle further, including a look at how IQVIA is positioning itself in early-stage biotech funding and what that strategy signals about where large CROs think the market is heading. Worth reading alongside the recording.

Watch the full session on demand

Forty-five minutes of context on where AI disruption in clinical research is actually landing, and where the Q4 data doesn’t yet support the narrative. Built for anyone making technology or investment decisions in the sector.

Watch now

Frequently asked questions

What did Q4 2025 CRO revenue and bookings data actually show?

Q4 showed bookings up year over year and accelerating across the major CROs, with revenues recovering in core direct services rather than just pass-through costs. Delays and cancellations, which had been severely elevated through much of 2025, moved into a more normalized range. ICON was the notable exception, with an internal accounting investigation announced in the same period adding company-specific pressure to broader sector sentiment.

Why did CRO stocks fall despite strong Q4 operational results?

Two factors intersected at the same time. First, a broader investor narrative about AI disrupting all software-as-a-service businesses created sector-wide pressure, catching CROs in the fallout despite their limited software revenue exposure. Second, how individual CEOs responded to AI questions on earnings calls mattered. Companies whose leadership arrived prepared with structured answers fared better than those who appeared caught off-guard. The data itself was not the problem. The narrative around it was.

How does AI disruption affect clinical operations software differently from drug discovery software?

The distinction matters a great deal. Regulated clinical operations software, including clinical trial solutions and eCOA solutions, operates under strict regulatory oversight that significantly limits the pace of AI-driven displacement. Drug discovery software companies, by contrast, are already experiencing measurable disruption in seat-based licensing, with several major players trading near all-time lows as of Q4 2025. The disruption is real. It just has not arrived uniformly across all segments of the industry.

Editorial note: During the live session, Joel mentioned that IQVIA had acquired Charles River’s preclinical platform. For accuracy: the acquisition agreement was announced in late February 2026 and had not yet closed at the time of the session. The body of this post reflects the correct status.

References

  1. White, J. (2026). Q4 2025 CRO and biopharma market update. Market Capital Consulting quarterly newsletter. Available via LinkedIn newsletter.
  2. Castor LinkedIn Live session: “The CRO Rebound and the AI-pocalypse: a Q4 industry post-mortem.” Recorded March 17, 2026. Featuring Joel White (Market Capital Consulting) and Derk Arts (Castor).
  3. IQVIA Holdings. (2026). IQVIA to acquire Charles River Laboratories’ early development services business. Acquisition agreement announced February 2026. IQVIA Investor Relations.
  4. White, J. (2026). Follow-ups on the Q4 recap for CROs and investors. Market Capital Consulting, published via LinkedIn Pulse, March 2026.

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What to look for in an EDC system: a practical guide for clinical trial teams

November 16th, 2022 by

Every clinical trial generates data across dozens of forms, sites, and time points. How that data gets collected, cleaned, and transferred determines how much of your team’s time goes to administration versus science. The right electronic data capture (EDC) system removes friction at every stage. The wrong one creates it.

This guide covers what an electronic data capture system actually does, the five operational benefits that matter most for study teams, what to look for during evaluation, and how EDC fits into the broader architecture of modern clinical trial solutions.

What is electronic data capture?

What is electronic data capture?An electronic data capture (EDC) system is software used to collect, clean, transfer, process, and store data in clinical trials. EDCs are used by contract research organizations (CROs), sponsors, and sites to conduct both simple and complex clinical trials in all phases of research. By using electronic records to capture and manage data on a digital platform, trial sponsors eliminate the need for traditional paper-based data collection. They can capture data securely and expedite the research process while ensuring data reusability.

Most EDC systems today are cloud-based so users can get secure access from anywhere. These systems collect varying types of data depending on the therapeutic area related to the clinical trial. For example, the data forms used in an oncology study might include:

The benefits of EDCs in clinical trials

The benefits of EDC in clinical trialsToday, clinical trials are typically expensive and time-consuming. Worse yet, they often create a burden for their participants. Trial sponsors are challenged to optimize every aspect of the research and development process to accelerate time to market, reduce the risk of failure, and retain participants along the way—all while staying on budget.

With the help of EDCs, sponsors can build clinical trials that meet the needs of regulators, payers, and participants. By using a foundational data platform that is flexible and interoperable, researchers speed up their research while lowering costs. Here’s how.

1. Incorporate real-world data (RWD) collection

An EDC solution simplifies and streamlines data collection. Once the data collection phase is complete, statistical processing can happen quickly. An EDC supports real-world evidence collection by:

Real-life example: COVID-RED

Julius Clinical’s COVID-RED (Remote Early Detection) study used wearable sensor technology and a smartphone app to measure participant vitals and provide personalized advice to get tested for COVID-19, even before symptoms appeared. The trial sponsors knew recruiting and collecting data from their 20,000-participant target would be incredibly challenging under ordinary circumstances—it would require multiple sites, complicated administrative processes, and in-person participant visits. And with 7,000 participants from a high-risk group safety during the pandemic was an issue.

Julius Clinical partnered with Castor to build an eClinical platform to run their trial remotely from start to finish. Through Castor’s clinical trial platform, over 17,800 participants were engaged and retained remotely, while data was automatically collected from thousands of medical devices and pushed into Castor EDC. According to the team at Julius Clinical: “Castor’s infrastructure ensured we were able to effectively carry out this study while keeping administrative burden, costs, and losses in participant engagement to a minimum.”

Julius Clinical's COVID-RED (Remote Early Detection) study

2. Directly capture global data

Clinical trials can be a global affair, with participants and researchers spread throughout the world. An EDC supports accuracy in international clinical studies through features like legible entries and automatic calculations. EDCs support global clinical trials by:

Real-life example: WHO Solidarity Trial

To combat the largest pandemic in recent history and generate sufficient evidence of the efficacy and safety of potential treatments, the World Health Organization (WHO) needed to mount a massive clinical trial.

The WHO needed a user-friendly system that they could deploy globally with 24/7 support. It needed to be advanced enough to support adaptive medication allocation and real-time reporting. Finally, offline data capture was a requirement due to unreliable internet in remote locations. The WHO approached Castor to help solve these challenges and quickly selected Castor as its sole EDC provider for the trial.

Castor quickly implemented a CRF in six languages, developed an adaptive randomization algorithm fitting WHO specifications, developed an offline capture tool for areas with poor telecom infrastructure, and provided 24/7 support.

“Launching and executing this ongoing trial is a remarkable achievement. In 6 months, the trial team accumulated information on the collective experience of more than 11,000 hospitalized patients in settings with varied and evolving standards of care.” – New England Journal of Medicine

3. Automate for the next generation of trial designs

Gone are the days of tedious manual data entry. Automation within clinical trials supports faster research and can speed up the return on investment of a trial. Automation within EDCs can benefit researchers by:

Real-life example: AusculThing

AusculThing seeks to transform the way healthcare providers detect heart murmurs by enabling them with a far more precise tool than the human ear. To train the algorithm to work more effectively, they would need to collect an enormous amount of audio and diagnosis data across 5 different sites.

The AusculThing team turned to Castor’s eSource platform, a system that would enable them to collect, capture, and process a significant amount of patient data from several sources, and feed it directly into Castor’s EDC. By the end of the trial, researchers had collected audio data recorded by a digital stethoscope and additional diagnosis info from over 1,700 patients – all without the need for manual source data verification. With data that’s healthy, integrated, and accessible through one interface, AusculThing can now train its AI algorithm much more efficiently and make considerable strides in creating an auscultation system that’s more accurate and efficient for healthcare systems worldwide.

Castor’s eSource was used to connect all data sources

4. Streamline collaboration workflows

Throughout studies, trial teams, monitors, and auditors need to capture, process, and access data from anywhere, at any time. EDCs allow data to be quickly shared with relevant personnel, enabling efficient exchange of information by:

Real-life example: RSP Systems—Using Monitoring to Track Study Progress

Over the past few years, RSP Systems has worked to bring their GlucoBeam monitor to market as a non-invasive and convenient glucose monitoring technology for diabetes patients. To do so, they’ve conducted multiple small clinical trials testing various settings on the device to improve protocols, estimate the signal-to-noise ratio, and increase the accuracy of the measurements. But the success of their studies depended on gathering highly accurate data ready for analysis. And with multiple trials running—some multicenter—they needed a bird’s eye view of all their studies with minimal manual effort.

Using Castor EDC, RSP Systems can now capture clinician, patient, device, and any other external data and get a complete overview of all the data linked to an individual patient. In particular, they’ve made great use of the monitoring feature in Castor EDC for a comprehensive overview of all the queries, data validations, and dropped verifications in each of their studies. They could find all the active validation fields in their study forms, reports, or surveys and easily filter by the type—Exclusion, Warning, and Message. From there, they could find out from which site the validation errors originated, compare the field values with the reference values defined during the validation setup, and jump to the step with the validation errors.

Woman testing glucose level with continuous glucose monitor

5. Manage mid-study changes with ease

EDC systems are flexible and adjustable, helping to meet the needs of the study as they change throughout the process. They support mid-study changes by:

Real-life example: AKRN Scientific Consulting

AKRN Scientific Consulting joined forces with a medical device manufacturer to innovate a way to keep a donor heart oxygenated in transport to its recipient. Together, they designed a clinical study to test their transportation solution. They then partnered with Castor to help design a clinical research ecosystem that would keep up with the evolving needs of the study.

As the randomized clinical trial expanded into several sites in different countries, study managers wanted to incorporate feedback from various study monitors and participants while still accommodating the varied regulatory and clinical needs. The protocol needed to be a living document that could evolve, reflecting the advice and parameters of each site. Fortunately, Castor’s eCRF made this possible, allowing changes to be quickly programmed and automatically uploaded to each site. As a result, each site always had the most up-to-date version of the eCRF.

What features should you look for in an EDC?

While choosing an EDC is a significant investment of both budget and time, the operational savings over the course of a study make it well worth the evaluation effort. Here’s what to prioritize:

How EDCs fit into the future of clinical research

Currently, clinical trials use isolated technology tools—such as eCRFs—to collect, manage, and analyze data. eCRFs are study forms built into EDCs that let researchers and clinical staff enter data directly into the system. These digital, typically web-based questionnaires ensure data compliance with privacy, security, and Good Clinical Practice regulations. Researchers can tailor eCRFs to fit each study, saving time and money.

While eCRFs represent a meaningful improvement over paper-based data entry, they remain a component within a broader, connected ecosystem rather than an end in themselves. The clinical trial industry is moving from siloed, cumbersome processes to decentralized clinical trials and fully connected, interoperable platforms for collecting and analyzing data. That shift involves pairing an EDC with the broader eClinical stack—eConsent, scheduling, televisits, and data from devices, consumer wearables, and patient apps.

An API architecture setup allows data collection from almost any source, and the goal is straightforward: a single system to collect, store, and process all clinical trial data. Therapy breakthroughs happen faster when researchers have access to affordable, user-friendly, and compliant data solutions. In just a few clicks, researchers can build a study with Castor’s clinical trials platform—without any prior technical knowledge—and grow alongside Castor as they move into fully integrated trials.

Frequently asked questions about EDC systems

What is the difference between an EDC system and a CDMS?

An EDC (electronic data capture) system is the tool used to collect and clean clinical trial data at the point of entry. A CDMS (clinical data management system) is the broader infrastructure that manages data across the full lifecycle of a study, including storage, processing, and export. In modern platforms, the two functions are typically combined: the EDC captures data from sites, devices, and patients, while the CDMS layer handles validation, query management, and data lock.

How does an EDC integrate with ePRO and eCOA tools?

Modern EDC platforms connect to ePRO and eCOA solutions via API, allowing patient-reported data to flow directly into the trial database without manual transfer. The EDC applies the same edit checks and data validation rules to patient-entered data as it does to site-entered data, maintaining a single audit trail. This is especially important in studies where patient-reported outcomes are part of the primary or secondary endpoint package.

What should I look for in an EDC for a decentralized or hybrid clinical trial?

For decentralized clinical trials, the critical EDC requirements are: remote participant access for direct data entry, device and wearable data ingestion via API, offline data capture capability for sites with unreliable connectivity, and native ePRO/eCOA integration. Additionally, look for built-in eConsent workflows and the ability to configure site-specific data collection rules without rebuilding the entire study structure.

What data standards should an EDC support for regulatory submissions?

For FDA and EMA submissions, CDISC standards are the primary requirement: CDASH for data collection forms and SDTM for data submission. Your EDC should either natively produce SDTM-compliant outputs or integrate with a data transformation layer that maps from the collection format to submission format. Systems that build CDASH compliance into the eCRF design stage reduce the transformation burden significantly at data lock.

How does an EDC reduce data errors and query burden in clinical trials?

EDC systems reduce errors at the source through built-in edit checks, plausibility constraints, and range validations that flag problems the moment data is entered—before it becomes a query. Auto-generated queries notify data managers and sites in real time, while medical coding standardizes terminology across sites and countries. The result is fewer discrepancies at database lock and less time spent on manual query resolution during the study.

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Beyond the EHR: meeting the FDA’s new real-world evidence standards

April 26th, 2026 by

For years, the use of real-world evidence (RWE) in regulatory submissions has required managing complex privacy constraints, fragmented data standards, and ambiguous agency expectations. A series of recent regulatory updates has fundamentally shifted this landscape.

Between December 2025 and March 2026, the FDA issued two distinct but highly complementary pieces of guidance regarding Real-World Data (RWD). While one targeted medical devices and the other focused on drugs and biologics, together they signal a unified regulatory philosophy: the FDA is lowering the privacy barrier for RWD while significantly raising the requirements for data structure and provenance.

For clinical operations and data strategy leaders, understanding the nuances of both pathways is critical for adapting to this shift.

A side-by-side assessment: devices vs. drugs

December 2025

Medical devices: lowering the privacy barrier

The FDA created a conditional pathway for de-identified RWD in medical device submissions, significantly reducing the requirement for individually identifiable source data. This lowers the operational and legal friction involved in using large-scale post-market registries for regulatory decision-making. Regulatory attorneys across the industry view it as a leading indicator that similar flexibility for drug and biologic submissions may follow.

March 2026

Drugs and biologics: raising the quality requirements

The FDA adopted ICH M14, establishing explicit standards for how sponsors must design, analyze, and report non-interventional pharmacoepidemiological studies used for post-approval safety assessment. An EHR export is no longer sufficient on its own. Study design, data provenance, and statistical approach must all be pre-specified and documented to the ICH M14 standard before submission.

Medical devices: lowering the privacy barrier (December 2025)

In December 2025, the FDA finalized guidance that sent a strong signal to the life sciences industry by relaxing the requirement for individually identifiable source data, and creating a conditional pathway for de-identified RWD when using RWE in medical device submissions.[1]

Drugs and biologics: raising the quality requirements (March 2026)

In March 2026, the FDA adopted ICH M14: General Principles on Planning, Designing, Analyzing, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines, a harmonized international guidance developed in collaboration with EMA and PMDA.[2] While the device guidance created flexibility around identifiability, the drug guidance raised the methodological bar.

Note: The FDA’s separate draft guidance covering non-interventional studies for both safety and effectiveness (“Considerations Regarding Non-Interventional Studies for Drug and Biological Products”) was issued in March 2024 and remains in draft as of this publication.[3]

The shared destination: enriching RWD with patient perspectives

Because the FDA is increasingly focused on the patient perspective alongside clinical endpoints, relying solely on administrative claims or EHR data is often insufficient. To meet regulatory standards, sponsors are increasingly combining retrospective clinical data with prospective, direct-to-patient data collection via electronic patient-reported outcomes (ePRO).

We see this exact shift in our own platform data. Across the Castor platform today, over 360 observational and registry studies are actively enriching their clinical datasets by capturing more than 16.4 million patient-reported data points. Sponsors recognize that pairing clinical data with quality-of-life and patient-reported outcomes is a defensible way to satisfy regulatory scrutiny.

The technology imperative

If sponsors are going to submit pseudonymized RWE to support a regulatory decision, the agency still needs to trust the origin and integrity of the data.

The important distinction is between de-identification and pseudonymization. At the study conduct level, data must be pseudonymized: direct identifiers are stripped for the sponsor and regulator, while a secure coded link is maintained at the investigator level for safety reporting and source data verification. True de-identification, which severs that link entirely, is generally inappropriate during an active study because it makes source data verification and adverse event follow-up impossible. The FDA’s December 2025 device guidance accepts de-identified data at the point of regulatory submission, where the audit trail has already been captured during the study itself.

This requires infrastructure built on modern data standards: CDISC for regulatory output (required for FDA submissions) and FHIR for EHR data ingestion (an FDA-encouraged standard currently under active evaluation for RWD submissions).[4]

At Castor, our clinical trial solutions are powering 1,077 observational studies and registries encompassing over 627,000 patients globally.

1,077 observational studies · 627,000+ patients

active on the Castor platform

Across that volume, we see a distinct trend: sponsors are building reusable, interoperable data assets rather than single-submission registries. This requires infrastructure capable of ingesting EHR data via FHIR, integrating prospective ePRO, and producing CDISC-compliant output with full audit trails. Castor’s Catalyst platform is built to this specification. By maintaining full audit trails without exposing Protected Health Information, this infrastructure provides the exact defensibility the FDA requires.

In practice: the Kaleido Registry

To understand how this shift plays out operationally, we can look at large-scale commercial deployments on the Castor platform. The Kaleido Registry, a prospective commercial registry, successfully enrolled nearly 34,000 participants across 8 sites. Rather than relying solely on administrative site data, the sponsor deployed a high-volume ePRO strategy to capture over 117,000 patient-reported data points directly from the participants. This approach reflects the direction both guidance documents point: large-scale observational datasets that integrate patient-reported data at the point of collection, rather than appending it retrospectively.

Conclusion: building for the long term

The 2025 and 2026 RWD guidance changes provide a clear framework for the future of clinical development. The FDA has outlined a pathway for faster, more pragmatic evidence generation across both devices and drugs, provided sponsors can meet the heightened expectations for data provenance.

For mid-size biotechs and MedTech organizations, the immediate action item is evaluating the foundational architecture of their observational studies. A registry designed only to satisfy a post-market surveillance requirement captures limited downstream value. A registry built on interoperable, pseudonymized infrastructure, with prospective ePRO built in from the start, can support subsequent label expansions and serve as a reusable data asset across the product lifecycle.

Organizations that build interoperable, audit-ready data infrastructure now will be better positioned to meet current FDA standards and to repurpose registry data for lifecycle management as their product pipelines mature.

Diagnostic: assessing your RWE readiness

Use the questions below to evaluate your organization’s current position relative to the 2025 and 2026 FDA guidance requirements.

For MedTech and device leaders

For pharma and biotech leaders

References

  1. FDA. “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” Finalized December 18, 2025. fda.gov/regulatory-information/…
  2. FDA. “M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines.” Federal Register, March 4, 2026. federalregister.gov/…
  3. FDA. “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products.” Draft guidance, March 2024. [In draft as of April 2026.] fda.gov/regulatory-information/…
  4. FDA. “Exploration of HL7 FHIR for Use in Study Data Created from Real-World Data Sources for Submission to the FDA.” Federal Register, April 2025. federalregister.gov/…

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On-site ePRO in Action: A Recap of Castor’s Product Spotlight

September 23rd, 2025 by

Remote desktop and mobile ePRO has been in Castor for years, but in more recent customer conversations, one ask kept coming up: can we extend our current assessment solution to a controlled, on‑site setting?

 

And that’s what we built. We extended that remote functionality into our core platform for clinicians to access directly. So they can capture participant data in-person while staying aligned with the flexibility and compliance of remote ePRO.

 

Our recent Product Spotlight with our product experts Christian (Product Manager) and Dualtagh (Manager Solutions Consulting) detailed exactly how the solution works. But in case you missed it or would like a recap, below is an overview.

 

Flexible data capture for sites and patients

 

We designed our on-site ePRO to reduce burden on sites without the reliance on hardware. The functionality is modular to our existing ePRO solution. It doesn’t require an extra app or device, and entries flow into your CDMS alongside your other ePRO data.

 

After starting the on-site session, staff can hand over their device or display a QR code for the participant to continue on theirs. If time in the clinic runs short, progress is saved and the participant can finish up remotely—no duplicate records, no re‑entry. You can switch modes at any time and preserve progress.

 

“The whole point is that there are different completion options with our on-site ePRO. We know that sites often have a pile of devices at study sites,” Christian explains. “Crucially, our solution is device agnostic. It ultimately scales and flexes to the device that you’re using and that you already have rather than adding yet another thing to that pile of devices at your site.”

 

For studies

 
Our On-site ePRO allows for direct and enhanced data capture on the site at FPI. Collecting those ePROs on site at baseline ultimately results in fewer gaps before intervention. 
 

“Missing, inconsistent, or poor quality ePRO data—particularly at baseline—ultimately jeopardizes trial endpoints,” Christian recognizes. “And we all want to avoid that ‘missed data on the patient clipboard in the lobby syndrome’ where they get given the clipboard, enter only parts of the data, they then leave, and have to then come back or be brought back at another point to enter that data.”

 

For patients

 

If a participant prefers their own device—even in a controlled site environment—we let them use their own device. Participants choose what’s comfortable in the moment—clinic device or their own—while keeping the option to finish later without starting over.

 

“It’s much more flexible, it’s kind of part of that broader level of support for decentralized and hybrid trials—complementing the remote data capture and creating that seamless data continuum,” Christian says. “So no matter where they are, no matter what devices they have, no matter what point in the trial they’re at, we can still capture that data safely, securely, and consistently.”

 

For data managers

 

On-site ePRO ultimately ensures standardized capture under controlled conditions, improving reliability for regulatory review. Which in turn, improves the overall compliance tracking. Sites can immediately verify data entry, reduce lag, reduce dropout, and have the data sit alongside all of the other data in the same, consistent, compliance report.

 

Christian concludes, “I think one of the biggest benefits of the module is how wonderfully simple it is. It kinda just works, and leverages our existing assessment technology.”

 

How it works

 

As a site user, you can access the solution via a button in the existing platform, opening up a link in the browser that you can bookmark, or add as an icon on your tablet.

 

After opening the module, you’ll log in and be presented with the on-site administration page, where you select the participant, visit, questionnaire and the participant’s language. Next you’ll verify the participant’s identity and select how to administer the survey.

 

You’ll be presented with two options: 

 

Using the site device

 

Using the site device as a participant, you’ll be presented with a clean and simple interface. You can start navigating through the questions and a progress bar on the left will provide you with an indication of the completion percentage. 

 

“While I’m completing the survey as a participant, that data is auto saving immediately,” Dualtagh explains. “It’s syncing back with the participant’s record within our overarching CDMS. So it’s making sure that data is immediately available for the site to review as well. At the site, and against the record.”

 

When the participant is finished, they confirm that they’ve completed their responses and will be presented instructions around returning the device. When they confirm and hand the device back, the site user will be logged out to prevent the participant from seeing any information.

 

The site user can then log back in and will be taken to the administration page again, where they can select the next participant and move forward.

 

Using the participant’s device

 

When using the participant’s own device, they’ll scan the QR code presented on the site device. 

 

Just like with the site device, the participant is presented with a clean and simple interface they can navigate through, and the data is auto saving and syncing back to their record.

 

“It’s just another way in which we can provide that little bit of extra flexibility, for data capturing scenarios where you don’t have that site-based device available,” Dualtagh highlights.

 

Using remote back up

 

When you make use of any of our remote back-up options, the participant will be emailed a link to the questionnaire where they can pick up where they left off.

 

Tracking compliance

 

Within our CDMS, the compliance dashboard gives you a quick overview of the overall compliance across participants in the study. You can use filters to drill down into the compliance in the last 7 days, 30 days, or all time; or, for example, hiding the 100% compliance entries.

 

You can use more detailed filters to drill down into data, for example based on specific site statuses, or a compliance percentage window.

 

You can also have a look at the specific surveys that have been sent, and dig into the participants to follow up with to ensure good compliance across your study.

 

“And this really just goes alongside some of our broader functionality for patient reported outcomes,” Dualtagh says. “It sits nicely alongside things like our patient reminders and different notifications for different modalities. So, the ability to remind patients via SMS, via web, via WhatsApp, and these different means to keep them engaged.”

 

Find out more about Castor’s On-site ePRO

 

Want to know more? We’re happy to answer questions or get you set up.

 

For existing customers, studies, and researchers:

 

The On-site ePRO module can be activated by your account manager. Contact them directly or email [email protected].

 

For new customers, studies, and researchers:

 

Contact the Castor team here to get started with Castor ePRO, or email [email protected].

 

Of course, you can also watch the webinar here. 

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Today’s Challenges for Digital Therapeutics

January 5th, 2022 by

DTx growth transcends old barriers, presents new challenges

Recent years have seen transformative technological advances—pushed partly by the urgency generated from the COVID-19 pandemic. The need to evolve has affected many industries, Digital Therapeutics (DTx) included.1 DTx manufacturers face fresh challenges in completing clinical trials and commercializing their products. Thankfully, with careful planning and help from the right allies, DTx manufacturers can successfully adapt.

todays-challenges-in-digital-therapeutics

DTx are evidence-based software programs that allow patients and (remotely) their care teams to prevent, manage, or treat a medical disorder or disease.2 DTx usually focus on chronic and behavior-modifiable conditions—everything from diabetes to insomnia to substance use disorders. DTx push the boundaries on what is possible when healthcare meets tech. For example, Renovia’s FDA-approved leva® provides potentially more effective relief than traditional interventions for chronic fecal incontinence.3 Like other medical interventions, such as medications and medical devices, DTx undergo rigorous testing for approval and use.  

DTx market expanding

Grand View Research’s recent report on the DTx market projects expansion at an astonishing 23.1% compound annual growth rate from 2021 to 2028. The following factors can explain this growth:4

  1. As awareness of DTx grows, patients, providers, and payers are now accepting them as valid treatment options.
  2. The pandemic has highlighted humanity’s need for mental health services and convenient and accessible digital health solutions. 
  3. Pandemic-generated urgency changed the pace of regulatory approval. Regulation requirements were suddenly widened to accommodate new and higher-tech approaches to research and medicine. Revisions may speed up the overall regulatory support for next-generation medicine. 
  4. Increased smartphone usage across the globe means more access to DTx and remote healthcare.    

Emerging challenges

New challenges have replaced previous woes despite growing acceptance and the healthcare industry’s increasing demand for DTx. In May 2021, Castor interviewed Chris Bergman, president of Amalgam Rx, about his thoughts on the future of DTx. Bergman identified previous issues as lack of funding, regulatory ambiguity, and a hesitant market. Current issues, according to Bergman, have shifted to establishing evidence, creating adequate payment and business models, and effectively increasing distribution and scale. A few years ago, DTx were scrambling to navigate regulations and establish themselves as valid healthcare options. Today they are making changes to improve growth and prove efficacy.5

Planning for new challenges

DTx manufacturers can meet today’s challenges through careful planning during the development stage. According to Bergman, DTx manufacturers do well to consider the following before commercializing their products:

Another way to meet new challenges is through strategic alliances. Data management platforms, such as Castor, can fill gaps in DTx manufacturers’ experience in trial development, security, and management. Utilizing innovative tech in clinical trials saves time and money, protects patients’ data, and contributes to trial success—a must in today’s healthcare scene.

The COVID-19 pandemic brought unforeseen changes to the DTx market. Initial challenges such as payer adoption, patient acceptance, and (even) regulatory ambiguities no longer stand at the forefront of challenges for DTx manufacturers. Instead, manufacturers have to deal with how to prove efficacy and ensure product distribution at scale with proper reimbursement. Investing in trial tech, such as Castor products, will help DTx manufacturers meet these challenges. 

 

1Llopis G. Digital Therapeutics are accelerating personalization in healthcare. Forbes. https://www.forbes.com/sites/glennllopis/2020/08/09/digital-therapeutics-are-accelerating–personalization-in-healthcare/?sh=34001c2c2176. Published August 9, 2020. Accessed September 3, 2021.
2Understanding DTx. Digital Therapeutics Alliance. https://dtxalliance.org/understanding-dtx. Accessed August 26, 2021.
3Renovia. October 29, 2021. Renovia receives Breakthrough Device Designation for leva® Digital Therapeutic as first-line treatment for chronic fecal incontinence [press release].
4Digital Therapeutics market size & trends report, 2021-2028. Grand View Research. https://www.grandviewresearch.com/industry-analysis/digital-therapeutics-market. Published April 2021. Accessed September 3, 2021.
5The future of digital therapeutics and the impact on care. Linus https://www.thelinusgroup.com/blog/digital-therapeutics. Accessed September 3, 2021.

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Electronic Patient Reported Outcome (ePRO) Measures: Questionnaires & More

November 10th, 2020 by

Patient reported outcome measures in clinical trials have traditionally been done on paper. Surveys are a common way to collect data from study participants. Surveys are questionnaires that allow data to be collected from a predefined sample in a population [1].

Electronic Patient Reported Outcome Measures Man Using Questionnaire on Mobile Device

What are patient reported outcome measures?

Patient reported outcome measures, or PROMs, are an easy method for measuring a patient’s health status or health-related quality of life. These capture data from moments in time through medical questionnaires which patients complete independently [2].  

By filling in the questionnaires, patients directly report on how their symptoms, daily functioning and general well-being are perceived during the study. Therefore, PROMs ensure to record not only the researcher’s observations and interpretation but the patients’ perspective on their own health.

Why are patient reported outcomes important?

The broad goal of clinical trials is to improve healthcare and its outcome for the population. By collecting patient reported outcome data, researchers get a brief insight into the frequency and variety of symptoms as well as the disease’s actual impact on daily life. These findings can later be used to close the gap between clinical research and therapy to ensure a patient-centered and high-quality care practice

In the past, surveys have been administered on paper, which requires tedious administration and logistics, and can also pose a private health information security risk. Thanks to advancement in digital technology, it is now possible for researchers to easily collect data electronically and in a secure way using tools like ePROs (electronic Patient Reported Outcomes) or eCOA. Patients can complete secure electronic surveys sent via email, saving time, increasing engagement, and requiring less administration. At the moment, more than 26% of studies in Castor are using surveys.

electronic Patient reported outcome measurements

Benefits of eCOA / ePRO

  1. Electronic medical questionnaires are easy to distribute:

    A major benefit is a more efficient and streamlined workflow, equating to time saved for researchers and participants. Often, for example, travel time to the clinic for data collection can be a barrier for participants and negatively impact the study, especially when researching rare diseases or small gene pools [3].However researchers should use tools designed and built for medical research, both for security and data compliance.

  2. Electronic Surveys are cost effective, requiring minimal research power to reach people and collect data.

    With the correct electronic data capture (EDC) tool, researchers can send patient questionnaires directly from the system and do not need to import or copy data from paper. Well designed surveys will collect high quality relevant research data, but require careful crafting and evaluation of wording and questions [4].

As discussed above, medical questionnaires need to be well crafted to ensure they are valid and reliable. It is also important to ensure that the correct population sample is selected. As with all study designs, surveys can introduce bias as a result of poor responses or no-responses (researchers’ cognitive bias).

How to create good clinical outcome assessments

epro-patient-surveys-castor

As researchers, the challenging task lies in creating a well designed patient questionnaire that measures what it claims to measure ensuring that it is valid. External validity is important for the generalizability of the study, ie. are the inclusion or exclusion criteria properly defined, can the results be applied to a population [4]. And internal validity is related to the robustness of the study, ie. does it have sufficient statistical power, proper control groups, randomization and blinding necessary for clinical trial research [4]. And a reliable questionnaire that will produce consistent results upon repetition [1].

When generating a patient questionnaire, the questions can be close-ended or open-ended. With close-ended questions, researchers set the range of answers on a scale or a range of tick-boxes [1]. Open-ended questions or free text can enrich quantitative data, and researchers will want to plan in advance how this data will be analyzed [1].

Standardized questionnaires can also be used, see an example below of an EQ-5D Questionnaire from Kieran Bond of Aridhia [2]. These widely used forms ensure that a high level of validity and reliability is achieved throughout the research.

Example of an EQ-5D Questionnaire in Castor EDC
Example of an EQ-5D Questionnaire in Castor EDC

These widely used forms ensure that a high level of validity and reliability is achieved throughout the research.

Using Castor eCOA / ePRO to send medical questionnaires to patients

With Castor eCOA / ePRO you can create complex surveys in minutes, using more than 21 field types, pre-built templates, and validations. You can also reduce time spent on rebuilding surveys from scratch by reusing existing surveys.

You can choose from tried and tested electronic surveys shared by Castor users in the Castor Form Exchange. Standardized forms, for example, those that measure quality of life, can be easily downloaded and re-used.

By using Castor’s automation engine you can increase participant enrollment, retention, and experience through automated patient engagement. You can also easily manage survey participants through bulk invites, automatic triggers, and a dynamic dashboard.

Researchers can schedule surveys and create emailing schedules to distribute patient questionnaires on certain dates or according to a custom timeline.

 

Using encrypted email addresses, clinical data entry is combined with outbound survey invitations sent to study participants. And at the push of a button, researchers can send a clinical outcome assessment to hundreds of participants, monitor its status and see results directly in the study dashboard.


Check out our webinar on how to build surveys in Castor eCOA / ePRO.

 

 

Sources:

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC420179/
  2. https://www.aridhia.com/blog/building-trust-and-improving-participation-in-clinical-trials-using-innovative-electronic-data-capture-platforms/
  3. https://www.bmj.com/content/350/bmj.g7818
  4. https://www.bmj.com/about-bmj/resources-authors/article-types

 

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Castor Is Committed to Scalable FAIR Data

October 1st, 2018 by

Success in life sciences research is all about transforming research findings into actionable knowledge. In this context, FAIR stands for Findable, Accessible, Interoperable and Reusable data, four critical elements to improve research infrastructure, making it easier for researchers to collaborate, ultimately improving the quality of healthcare in general.

#FAIRdata is a key topic at The Dutch Techcentre for Life Sciences (DTL)’s 2018 Conference, which we are proud to support. DTL provides a helpful description of each of the four elements on their website:

Findable – Data and metadata should be easy to locate, both by humans and by computer systems. Basic machine-readable descriptive metadata enable the discovery of interesting datasets and services.

Accessible – Stored for long term so that they can easily be accessed and/or downloaded with well-defined license and access conditions (open access when possible), whether at the level of metadata, or at the level of the actual data

Interoperable – Ready to be combined with other datasets by humans or computers

Reusable – Ready to be used for future research and to be further processed using computational methods

These FAIR principles are perfectly aligned with Castor’s goal of helping “accelerate medical research by unlocking the potential of every byte of research data.” 

Click here if you would like to learn more about the FAIR data specification.

Concerns over data quality and usability

Over the years, as an MD and a researcher myself, I have become more and more concerned about the quality and the (re-)usability of data. In fact, approximately 85% of medical research data is never re-used due to poor data quality, lack of standardization, and by the data being inaccessible to others. I started Castor EDC in 2012 to address these issues and was happy to learn about the FAIR principles, which were published in 2016. This, in addition to other important initiatives such as the European Open Science Cloud (EOSC), are fostering global data findability and accessibility.

Open Science is an umbrella term for new technologies and a data driven systemic change in how researchers work, collaborate, share ideas, disseminate and reuse results. It is built on a foundation of core values that knowledge should be reusable, modifiable and redistributable.

The Commission “High Level Expert Group European Open Science Cloud” chaired by Barend Mons has published a first report on how the EOSC can be realized.

You can learn more about DTL’s vision regarding Open Science here.

Incorporating FAIR principles into Castor EDC

At Castor, one of our main goals for the next few years is to become a pioneering player in the field of Open Science. This means we will prioritize the development of data FAIRification within Castor EDC. By allowing researchers to expose their Castor data in a FAIR manner, research data can be shared easily between research projects worldwide.

At the 2016 BYOD hackathon in Leiden, Netherlands, Castor’s CTO, Sebastiaan Knijnenburg, PhD, and I spent three days learning about the FAIR specifications and trying to implement them into Castor. In just three short days we managed to extend our API and transform Castor into a FAIR data point.

BYOD FAIR hackathon
Castor attending the 2016 “Bring Your Own Data (BYOD)” FAIR hackathon in Leiden, Netherlands.

We also managed to implement a Resource Description Framework (RDF) endpoint. We added semantic metadata to a Castor study and allowed the export of this study data in the RDF format. Two other software solution providers, OSSE (Open Source Registry System for Rare Diseases in the EU) and RDRF (Rare Disease Registry Framework) also worked on generating FAIR API endpoints for their software. (Learn more about medical device registry studies here.)

As a result, on the last day, data from a case study in all three systems could be queried and analyzed together, even though the original datasets were developed separately and did not share the similar structure.

Every dataset should be FAIR

In my view, every dataset in the world should become FAIR, not just those with funding to pay for FAIR data stewardship. This is why Castor is joining forces with several partners, such as DTL, that support Open Science to create an infrastructure that allows researchers to create semantic data models themselves. They can then actually create FAIR data at the source. Once we get this to work for all the studies in our system, FAIR will really start to shine. By enabling FAIR data at scale, researchers can easily make their clinical research data available for the FAIR research community. This way, both humans and computers will be able to search and filter through a dataset on a semantic level.

That said, semantic modeling is an area we can improve, as it is currently very labor intensive and can only be done with the help of experts. I have some ideas on making the creation of FAIR data accessible for everyone, and I will be working on these ideas in the coming years with FAIR scientists from across the globe.

Start small

As beautiful as fully interoperable, machine-readable data are, just the ability to find and access research data globally will make a big difference. Having the FAIR data points available, with a simple Comma Separated Value (CSV) download distribution for instance, will already be a big improvement in the short term.

The ultimate goal is user-created scalable content

We should work together towards enabling user-created scalable FAIR data. I think that would be the key to success. As soon as researchers start to realize the potential of FAIR –like the European Science Cloud– it will make a big difference in their attitude towards sharing data.

Furthermore, once people see the immense savings that a standardized data set can make, it could lead to initiatives that can contribute to making valuable medical data universally available.

Going forward

Showing the world how awesome user-created scalable FAIR data is and how useful it can be is a very important first step.

We at Castor have applied for grant funds to enable us to put more effort into working on scalable FAIR data and to demonstrate its overall benefits.

For additional background on Castor and our efforts to support FAIR data, here is a video completed for the 2016 FAIR hackathon:

 

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Castor joins forces with EuroQol to facilitate EQ-5D survey usage

June 27th, 2019 by

The EuroQol Research Foundation created EQ-5D to standardize how health-related measures such as Quality of Life and other healthcare evaluations are collected. This initiative is aligned with our quest to standardize medical research. And today, we are thrilled to announce that these EQ-5D modular versions are now available for Castor EDC users! 

Under this partnership,  Castor users can now make use of pre-made Castor EDC forms for the EQ-5D surveys. This simplifies the process of accessing and sending these surveys by eliminating the need for screenshot review by EuroQol.

The surveys are available in both Dutch and English, for EQ-5D-3L and EQ-5D-5L. Castor users can obtain these surveys by registering their studies on the EuroQOL website. For academic studies, Castor EDC’s EQ-5D modules can be used for free (after registration). For commercial studies, a license fee will be charged according to EuroQoL’s user policy.

A demo version of the Castor EQ-5D surveys can be found here. Give it a spin and tell us what you think!

Demo Request

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Bridging clinical efficacy and real-world effectiveness in digital therapeutics trials

January 25th, 2022 by

How real-world data capture closes the gap

No matter how conclusive clinical evidence is for medical treatments, developers may struggle to see precisely how their treatment performs in the real world—outside the controlled environment of the clinic or office. Do patients take the medication as expected while immersed in busy schedules? How often do they practice the exercises the therapist prescribes?

Unfortunately, medical treatments proven to work in clinical trials do not always measure up in the real world. According to Simon Makin’s “A smarter way to treat” article, one quarter to one half of the global population doesn’t take medications as recommended. In the U.S., this failure links to up to 125,000 deaths and costs up to $289 billion.1 The gap between efficacy and effectiveness is a significant issue impacting many.

Digital therapeutics provide real-world data capture

Enter digital therapeutics (DTx) and their unique ability to capture real-world data remotely. DTx are software-based, evidence-driven treatments for managing, preventing, and treating a wide range of medical conditions or illnesses.2 Unlike conventional medical interventions such as medications or medical devices, DTx can constantly gather data on patients’ involvement and progress—giving a crystal-clear view of how the treatment is working outside of a clinical setting.

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DTx capture data via software on patients’ devices or connected wearables. App data includes any biometrics recorded in the app, patient-reported outcomes, patient progress through software modules, and other data stored in the app, such as clinic visits and test results. While more traditional data collection methods are periodic, real-world data collection can be continuous and ongoing.3 When used effectively, the detail captured improves the data quality and helps demonstrate how users interact with the treatment in their everyday lives.4

These examples illustrate DTx real-world data capture:

Tech helps manage real-world data capture

Tech tools help DTx maximize the impact of the real-world data they capture. Technology can assist in every aspect of handling patient data—from collecting responses from digital patient surveys to capturing, processing, and integrating data from varied sources to securely tracking patients’ consent. Software developed specifically for DTx streamlines data capture and management, making it easier for DTx to get products to market and into patients’ hands. DTx real-world data capture can bridge the gap between how well researchers think their treatment functions (efficacy) and how well their treatment performs (effectiveness) outside of a clinical setting. Regular, remote data capture can transform how effective treatments can be and the type of people they can reach.

 

1Makin S. A smarter way to treat. Nature. 2019;573. https://media.nature.com/original/magazine-assets/d41586-019-02873-1/d41586-019-02873-1.pdf. Accessed August 27, 2021.
2Understanding DTx. Digital Therapeutics Alliance. https://dtxalliance.org/understanding-dtx. Accessed August 26, 2021.
3Sverdlov O, van Dam J, Hannesdottir K, and Thornton-Wells T. Digital therapeutics: An integral component of digital innovation in drug development. Clin Pharmacol Ther. 2018;104(1):72-80. doi:10.1002/cpt.1036
4Van Norman G. Decentralized clinical trials: The future of medical product development? JACC Basic Transl Sci. 2021;6(4):384–387. doi: 10.1016/j.jacbts.2021.01.011
5DTx product case study: Propeller. Digital Therapeutics Alliance. https://dtxalliance.org/products/propeller/. Accessed August 26, 2021.
6The Mabu care insights platform. Catalia Health. https://www.cataliahealth.com/platform-ai/. Accessed September 8, 2021.
7Patient-centered solutions. Catalia Health. https://www.cataliahealth.com/solutions/. Accessed September 8, 2021.

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A Digital-First Mindset Shift on eConsent

September 26th, 2023 by

eConsent plays a pivotal role in optimizing modern clinical trials, but the nuance around eConsent adoption for pharmaceutical and medical device companies remains a consideration for implementation teams. Castor CEO & Founder – Derk Arts MD, Ph.D. recently sat down with Leanne Walsh of Northern Light Lifescience to talk about the challenges, processes, considerations, and mindset shifts that study teams must consider when reviewing eConsent for their trials.

From the conversation between Derk and Leanne, as well as the audience Q&A, it’s clear that the question of eConsent isn’t so much of a “Why?” but a “Why not?” As one attendee noted, “This sounds like people [are] using eConsent in exactly the same way as paper though—in the clinic alongside a face-to-face conversation. If it is used as a tool to provide information to potential participants ahead of a clinic meeting or as a follow-up to the clinic, then it could add more value.”

Here are some of the key themes from the discussion:

eSignature vs. eConsent vs. Digital Signature: Are they the same?

The first barrier to eConsent adoption is getting over regulatory uncertainty. On the sponsor and site ends—especially in terms of signature use, misconceptions about “eConsent is only the eSignature” are still very prevalent. eConsent allows for additional sources of information that the participant can review ahead of time. All of this capacity is contained within the eConsent ecosystem and can happen before a visit to the site. Educating study designers and IRBs to understand that the informed consent process is its own ecosystem rather than just the signature element is a crucial step to break out the parts of eConsent that go well beyond just eSignature.

An electronic signature is always integral to eConsent. However, eSignature requirements vary by country, impacting eConsent adoption. In countries that do not accept eSignature, Castor’s research indicates that a participant can often sign a paper form while on the video call and then mail in that form. Although this method entails paperwork, you retain two key benefits: the eClinical platform tracks the consent status, and participants can access trial information online at any time.

“People’s perceptions are different right down to the basics around a signature and digital signature. Are they the same thing? And do they mean the same in the regulations from the FDA versus in Europe? Vendors should be responsible to convey what it means, clarify those terminologies, and make it simple for the study teams to understand.“

– Leanne Walsh, Director, Northern Light Lifescience

Read more from the FDA on Informed Consent for Clinical Trials. 

Digital vs. analog systems: Can eConsent enhance data retrieval over traditional paper processes?

The shift from analog to digital systems in the consenting process is not merely a trend but a necessity. Picture the traditional paper-based consenting process: physical folders, stacks of papers, and the ever-present risk of misplacing a crucial document. This analog approach, although familiar, presents challenges. As the volume of participants grows, so does the paperwork, leading to an increased risk of data loss.

Building on the insights from the webinar, there is an undeniable “wait and see” approach when it comes to adopting new technologies. This hesitancy is often rooted in the challenges of implementing features and the perceived complexities of digital systems.

But let’s debunk a myth: digital systems, especially in the consenting process, are designed to secure data storage. With everything stored electronically, data accessibility becomes seamless. If the study team needs to pull up a specific patient’s consent form, it is only a click away.

“What’s stopping sponsors from engineering their way into accessing clinical data is the concern that all the paper will get digitized in some shape or form and stored somewhere that is completely untraceable […] There’s no way a response would break into a digital system and override whatever access they have to. Then review data that they are not supposed to have access to. So I think it is unequivocally true that digital systems are actually safer and better in restricting access to information or giving access to the right information than analogue analog systems.“

– Derk Arts, CEO & Founder, Castor 

Shifting to a “digital first” mindset creates a larger move toward eConsent adoption among sponsors

The “digital first” approach not only highlights the safety and security benefits of eConsent over paper, it also helps study designers and IRBs experience the expanded capabilities of the whole eConsent ecosystem out in the open. Seeing the eConsent capabilities allows the clinical staff and study designers to plan for how to deliver the extra information that is customized to specific needs of participants.

Digital systems can enhance the patient experience by allowing researchers to develop tools that are more efficient, interactive, and personalized. They can give study participants enough flexibility and time to be better prepared for the consultation with clinicians, formulate questions, or use the waiting time efficiently if the tools are used in the waiting room.

However, the success of this approach hinges on timely adoption. By embracing the digital first mindset from the get-go, study teams can ensure that eConsent isn’t an afterthought but a foundational pillar of the study design. This proactive approach can catalyze conversations, ensuring that sponsors are aligned and onboard from the outset.

Watch the on-demand recording of eConsent from Sponsor to Site: Navigating Successful eConsent Adoption to take in the full conversation and hear about the impact of eConsent, real-world examples of eConsent evaluation, readiness, and implementation, and potential for future industry adoption. 

Discussion Highlights: 

 

Castor’s product suite ensures security, access, and ease of use for sponsors. Our ongoing innovations keep Castor software and technology poised to meet the expanding needs of clinical trials. Ready to learn more? Let’s chat.

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3 Ways eConsent Tackles the Challenges of Modern Clinical Trials

September 28th, 2021 by

Although eConsent struggled to gain momentum and wider acceptance pre-pandemic, it is actually powered by technology that is regularly used in daily life and is more approachable than one might think. Regardless, some researchers are still hesitant to embrace remote technology. In this article, we’ll explore three areas that researchers cite as obstacles when implementing eConsent: data safety; regulatory compliance; and identity verification. Read on to learn how these issues can be resolved safely and efficiently.

Playing it safe with data

Data integrity, safety, and privacy are of critical importance these days. And with good reason—never before has so much personal data been processed through online services. Since medical data is among the most private there is, clinical trials must adhere to the highest standards of data protection while offering their participants data privacy. Fortunately, there are several ways to accomplish this via  eConsent.

In order to keep data safe and secure, opt for an eConsent solution with:

When employing eConsent, investigators should use embedded HIPAA-compliant authorization forms to ensure FDA compliance. In the EU, the GDPR’s most recent guidance requires “an effective audit trail of how and when consent was given, so you can provide evidence if challenged” and “an appropriate cryptographic hash function to support data integrity.” 

Any video conferencing used as part of eConsent must be secure, traceable, and fully compliant. For example, it should be encrypted and US 21 CFR Part 11 compliant. 

Navigating the regulatory jungle

The regulatory jungle is complex enough to discourage researchers from changing established methods they know are fully compliant (or that they believe are fully compliant). . It doesn’t help that different countries and regions have their own regulations around the use of eConsent and acceptance of eSignatures. At the time of writing, the FDA’s most recent guidance was published in December 2016 and no EU regulation or guidance about eConsent in clinical trials exists.

Ensuring regulatory compliance is not hopeless, however. In general, Institutional Review Boards (IRBs) and ethics committee have consistent requirements for paper and electronic consent, such as:

Researchers need to familiarize themselves with their applicable IRB guidelines. (Find a handy overview of eConsent guidelines in twelve different countries here.) When making a submission for an eConsent-based study, it’s important to also address:

Checking IDs at the door

Clinical investigators need to confirm the identity of all participants in a trial according to regulatory requirements. But that doesn’t mean every participant needs to present themselves at the study site—video conferencing to the rescue!

An appropriate, secure video conferencing solution provides investigators with real-time, visual interaction with participants. This allows the study team to verify the identity and, if using a hybrid wet-signature with eConsent, witness the signature of each participant. But the benefits don’t end there—video conferencing allows a clinical researcher to answer questions directly, cementing trust with a participant and increasing retention. Importantly, investigators are able to observe the participant’s behavior and determine if they are capable of offering informed consent and are consenting of their own free will.

Castor eConsent is a flexible, user-friendly, and secure solution for your next trial. If you’re interested in learning more about putting eConsent to work in your next trial, reach out to one of our friendly Castorians here.

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Building Biotech: From Science to Scale – Strategic Lessons from the Frontline

May 28th, 2025 by

Biotech isn’t for the faint-hearted. As Derk Arts, CEO of Castor, and Professor Thomas Wurdinger discussed in their recent LinkedIn Live session, building a successful biotech company demands more than just groundbreaking science. Their conversation, titled “Building Biotech: From Science to Scale,” peeled back the layers on what truly drives success in early-stage biotechs. Spoiler: it’s less about having the best data and more about narrative, execution, and alignment.

Biotech, they argue, is the survival of the funded. It’s a terrain where the loudest story often drowns out the best science. Wurdinger’s own journey underscores this paradox. From his days as an RNA researcher to founding ThromboDx—a diagnostics company acquired by Illumina—and watching it evolve into Grail, his career exemplifies the rare but critical blend of academic depth and commercial savvy.

“Having the best data doesn’t guarantee funding, while poor data can often get you funded fast.”— Thomas Wurdinger

One of the most telling themes from the conversation is how market sentiment frequently trumps scientific merit. The Illumina-Grail case highlights this reality. Regulatory friction, misaligned expectations, and timing can vaporize billions in value overnight. In such a volatile landscape, a great idea needs more than validation; it needs strategy.

Wurdinger’s transition from the lab bench to the boardroom reveals the critical early decisions that separate promising biotechs from perishable ones. His threefold advice? First, founders must seek strong mentors who can help navigate intellectual property (IP), licensing, and fundraising. Second, never sign licensing or investment documents without independent legal counsel—no matter how friendly the university seems. And third, founders need brutal self-awareness: not everyone is meant to be a CEO, and clinging to titles can stall progress.

The tension between data quality and funding viability also took center stage. Many startups, especially those emerging from academic labs, struggle to convince VCs because their innovation doesn’t fit into the typical biotech investment playbook. Unlike therapeutic programs with clear regulatory and clinical pathways, platform or diagnostic companies must often invent their own roadmap—and articulate that roadmap convincingly to investors.

“Pride is your worst enemy when you’re in a startup.”— Thomas Wurdinger

This is where storytelling matters. Investors aren’t just betting on data. They’re betting on a vision, a team, and a well-crafted narrative that explains why now is the time, why this team is the right one, and why this solution matters. That’s why Wurdinger’s investment fund includes a filmmaker as one of the partners—to help founders construct that narrative arc. Because in biotech, your pitch deck is more than a slide show. It’s the first act of a story that investors must want to see through to its final scene.

While robust data underpins credibility, it’s often not the first thing investors see. Especially in early-stage funding, decisions are made based on the team, the problem-solution fit, and the ability to scale. Once a startup progresses, though, clinical readiness becomes critical. This includes preclinical validation, manufacturing scalability via CDMOs or CROs, and FDA registration planning. Without these, clinical trials are non-starters—and timelines slip fast.

Explore Castor’s tools for decentralized and hybrid trials

Wurdinger also offered pragmatic insight into fundraising phases. Many companies bridge the early-stage “valley of death” with government grants (like Eurostars) and local loans. Family, friends, and early believers play a crucial role, albeit a risky one. But to attract serious venture capital, companies need credible leadership, not just science. A seasoned CEO, clear go-to-market strategy, and defensible IP position are often the deciding factors.

Team-building was another recurrent theme. Founders should avoid perfectionism when assembling their leadership team. Instead, they need people who are aligned, resilient, and pragmatic. Equity dilution is not failure; it’s the price of momentum. The value lies in execution, not in retaining 100% of a stalled startup.

“You can’t get the best people in when you’re a startup and basically a nobody in startup land.”- Thomas Wurdinger

For first-time founders, Wurdinger left a final checklist: seek out mentors who challenge you; retain your own legal counsel; build your story before your data; and hire for your blind spots. Passion fuels the journey, but structure sustains it. No matter how disruptive your science, startups don’t scale themselves. They are built, step-by-step, through smart strategy, clinical readiness, and investor trust.

Platforms like Castor play a pivotal role here. As Wurdinger and Arts both noted, accelerating clinical operations through tech-enabled solutions is one of the few defensible edges in an increasingly competitive biotech ecosystem. With modern EDC systems, decentralized trial capabilities, and scalable workflows, Castor helps bridge the gap from hypothesis to human evidence.

The path from science to scale is long, but it’s navigable. With the right story, the right data, and the right team, even the most complex ideas can become transformative companies.

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The Catch-22 of eConsent: The Missed Opportunity for Improved Clinical Trials

March 13th, 2025 by

eConsent technology is often praised for its potential to revolutionize clinical trials, yet it remains underutilized. The promise is clear: better comprehension leads to better satisfaction, retention, and protocol adherence. But the reality is much bleaker. Many implementations fail to deliver on this promise because they treat eConsent as a digital version of paper forms rather than as a transformational tool. This article explores the barriers holding eConsent back, backed by evidence from scientific literature, and proposes actionable solutions.

Why eConsent Matters: The Evidence

Multiple studies have demonstrated that interactive eConsent tools enhance patient comprehension compared to traditional methods. Taylor et al. (2021) showed that video-based consent interventions significantly improved participants’ understanding of trial concepts compared to standard consent forms. Their randomized trial across six clinical studies found:

“Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process.” (p = 0.020).

Moreover, Glaser et al. (2020) highlight that 85% of interactive, teach-back-based digital interventions successfully improved comprehension outcomes. They concluded:

“Interactive interventions, particularly with test/feedback or teach-back components, appear superior.”

Retention is another critical metric tied to eConsent. Skea et al. (2019) emphasize that participants drop out when they don’t feel adequately informed or when trial demands are misaligned with their expectations:

“Initial decisions to participate may not have been fully informed, leading to mismatched expectations and eventual attrition.”

These findings align with broader educational research demonstrating that interactivity and multimedia boost knowledge retention. For example, multimedia learning theory shows that combining visuals, text, and interactivity engages multiple cognitive pathways, enhancing understanding.

The Catch-22: Barriers to eConsent Adoption

Despite these proven benefits, eConsent remains stuck in a vicious cycle:

“The term ‘eConsent’ is often misunderstood, with many platforms offering only weak ‘design’ functions, which do not fulfill the full promise of digital tools.”

“Current practices often fail to define adequate patient comprehension and to ensure its assessment as part of the informed consent process, leading to frustration among sites.”

Breaking the Cycle: Unlocking eConsent’s Full Potential

  1. Example 1: Incorporating Interactive Features
     Taylor et al. (2021) demonstrated that video-based eConsent significantly improved satisfaction and understanding. If we give patients a short a video explaining key trial concepts, followed by an interactive quiz, we have already made real progress. This approach not only improves comprehension but also creates an audit trail for compliance.
  2. Example 2: Leveraging Educational Theory
     Studies on digital learning suggest that chunking information into bite-sized pieces and using visual aids enhances retention. A trial sponsor could use animated videos to explain randomization or potential side effects, coupled with glossary tools to define medical terms. Such tools could reduce dropout rates and enhance patient confidence.
  3. Example 3: Quantifying ROI
     Consider a large, global trial where dropout rates are reduced by just 5% through better eConsent. This could save millions in recruitment and operational costs. To encourage adoption, sponsors should calculate and share these savings, framing the initial investment as a long-term cost-saving measure.

Finally: just doing the right thing

Beyond the financial and operational arguments, eConsent represents an ethical obligation. As Pietrzykowski and Smilowska (2021) emphasize:

“The informed consent process actually leads to patients’ full comprehension of what they are consenting to. Unless this assumption is demonstrably true, the ethical viability of current medical experimentation practice is seriously flawed.”

This is also where I feel strongly. We are submitting patients to incomprehensibly long consent forms, knowing that comprehension will be low, but at least we’ve covered our legal bases.

Using multimedia and personalized tools isn’t just about better trials—it’s about respecting participants’ autonomy. When patients fully understand what they’re agreeing to, every stakeholder reaps the rewards.

To summarize, we must:

It’s time to move beyond treating eConsent as a checkbox and realize its full potential. The technology is ready—now the industry must commit to using it to create better, more ethical, and more successful clinical trials. Let’s break the cycle.

References

  1. Taylor et al. (2021). Randomized comparison of two interventions to enhance understanding during the informed consent process for research. Clinical Trials, 18(4), 466–476. doi:10.1177/17407745211009529
  2. Glaser et al. (2020). Interventions to improve patient comprehension in informed consent for medical and surgical procedures: An updated systematic review. Medical Decision Making, 40(2), 119–143. doi:10.1177/0272989X19896348
  3. Skea et al. (2019). Exploring non-retention in clinical trials: A meta-ethnographic synthesis of studies reporting participant reasons for drop out. BMJ Open, 9(6), e021959. doi:10.1136/bmjopen-2018-021959
  4. Vanaken et al. (2024). Effective eConsent strategies for every study: Utilizing the eConsent fit-for-purpose study framework. Applied Clinical Trials. Available online.
  5. Pietrzykowski & Smilowska (2021). The reality of informed consent: Empirical studies on patient comprehension—Systematic review. Trials, 22(1), 57. doi:10.1186/s13063-020-04969-w

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Measuring the true patient experience in Cancer Trials with eCOA / ePRO

March 22nd, 2024 by

Our recent webinar featuring PRO expert Ari Gnanasakthy, RTI Health Solutions, and Derk Arts, CEO & Founder, Castor, sheds light on the complexities and advancements in measuring PROs, drug tolerability, and quality of life in cancer trials. Here, we distill the insights shared and explore the implications for future research.

Cancer studies are not what they used to be

Derk and Ari kicked off their conversation by discussing how cancer research is getting more and more complex and with this ever-evolving landscape, a focus on patient-reported outcomes (PROs) and clinical outcome assessments (COAs) has never been more critical. With the emergence of innovative treatments such as plasma-derived therapies, CAR-T therapies, reductions in chemotherapy cycles, and a surge in novel oral medications, the shift towards more personalized and targeted therapies underscores the necessity to move beyond traditional PRO methodologies.

In this new era, a more patient-centric approach is needed, ensuring that treatment strategies not only combat the disease effectively but also offer real-time insights into treatment efficacy, patient well-being, tolerability, and quality of life (QoL).

“Let’s stop talking about patient reported outcomes, instead let’s talk about the patient experience and the ways we measure QoL within all the nuances of cancer trials.“

– Ari Gnanasakthy, RTI Health Solutions

Navigating the regulatory landscape

The webinar delved into the changing regulatory landscape for cancer trials, particularly for measuring PROs. As treatments like CAR-T cell therapy become more prevalent, capturing the authentic patient journey has become more crucial for understanding both efficacy and safety. Regulatory bodies are increasingly emphasizing the importance of real-world evidence, pushing for a more comprehensive view of treatment impacts. This shift necessitates meticulous planning in data collection, not only to meet regulatory approval requirements but also to address the downstream needs of payers. Having this dual focus ensures that the collected information serves both immediate regulatory purposes and future payer evaluations, facilitating a smoother transition from clinical approval to market access. With the rise of personalized and targeted therapies, the reliance on outdated PRO methodologies is no longer viable. Clinical trial design needs to reflect a balance between scientific rigor and patient-centricity, ensuring research outcomes are both scientifically valid and meaningful to patients’ lives.

Who says the drug is tolerable?

The Patient. A critical aspect of the discussion between Ari and Derk centered on the concept of measuring treatment tolerability and QoL within cancer research. The conversation highlighted a need to shift perspectives, with emphasis on understanding how tolerability influences patient adherence and overall treatment outcomes. Ari emphasized the importance of viewing tolerability through a comprehensive lens and throughout treatment cycles.

“Tolerability is not something that can be measured at the beginning of each cycle when patients are reasonably healthy. Tolerability is something that needs to be measured when patients are having issues and when the drug is at peak, during cycles…probably on a weekly basis.”

– Ari Gnanasakthy, RTI Health Solutions

But how do we consistently measure something so subjective in a scientific way? Tolerability is not just one measure but a number of elements that need to be considered, including safety data, treatment data and PROs (like physical and role function, side effect burden or even hair loss). It is clear we need to consider both the physical and psychological nuances of patient experiences when assessing treatment tolerability.

Elements of treatment tolerabilityWhat does the future hold for ePRO?

Finally, Derk and Ari spent time looking ahead at how the role of technology and ePRO in cancer research is expected to expand. Wearables, BYOD (Bring Your Own Device) strategies and advanced scheduling for data collection will play pivotal roles, enabling real world data collection that reflects the true impact of cancer treatment on patients’ lives.

This digital-first approach is anticipated to improve data quality and drive more patient engagement. By engaging patients through their own smartphones and leveraging technology they are familiar with, clinical trials can more accurately measure the true patient experience, thereby improving participation and adherence. Additionally, ePRO technology offers solutions to challenges around data integrity and overcoming the “parking lot effect,” where responses may be influenced by the immediate environment of data collection. This evolution marks a pivotal step towards more patient-centric research and ultimately better outcomes.

“It’s now clear that we’re dealing with three layers of data. Initially, we have the core data that has been the focus for the past two decades. Added to this are scheduled QoL and tolerability data. The final layer encompasses wearable and ad hoc data, enriching our understanding of tolerability. This stratified approach presents a significant opportunity to enhance patient outcomes.”

– Derk Arts, Castor Founder & CEO

And, from the sponsor side, it’s imperative to consider the influence of Quality of Life (QoL) and tolerability measures on the drug’s value proposition. For sponsors, overlooking this aspect could lead to a significant gap in their value proposition.

The single line item from the FACT-G questionnaire, GP5, which asks patients if they are “bothered by side effects of treatment,” has demonstrated a strong predictive value for both patient dropout and disease progression when patients report being troubled by side effects. This underscores the importance of integrating patient-centric measures into clinical trial design and evaluation to enhance patient retention and treatment outcomes.

Getting started with Castor eCOA / ePRO

To deepen the understanding of eCOA / ePRO technology for sites and sponsors, and to ensure fast study builds, Castor welcomes study teams to explore our eCOA / ePRO platform by offering early access, and allowing them to personally navigate the patient experience. Our comprehensive onboarding process and dedicated customer support play a pivotal role in this commitment. Additionally, we provide the option to work with synthetic data upfront, offering a proactive approach to risk mitigation.

At the heart of our platform is a patient-centric approach, designed to significantly improve the trial experience for participants. By prioritizing the patient perspective, we aim to enhance engagement and collect valuable real-world data. This data is crucial for gaining insights into treatment effectiveness, patient well-being, tolerability, and quality of life, in the ever changing landscape of cancer research.

For more information, watch our on-demand webinar:
eCOA / ePRO and Cancer Research – Measuring the true patient experience

Follow us on LinkedIn: Castor

Learn more about Castor eCOA / ePRO

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The Place of COAs / PROs in the Future of Healthcare

March 9th, 2024 by

Over recent decades, we’ve witnessed a pivotal shift in the global healthcare landscape. As chronic conditions have become more prevalent, nations worldwide have been reevaluating their healthcare delivery models, moving away from traditional fee-for-service models towards a more outcomes-focused approach. Both governments and private payers are now pondering a critical question: “How can we reimburse healthcare providers based on the positive outcomes for patients, rather than just for the services they provide?”

Value-Based Care

Value-Based Care (VBC) programs represent a transformative approach in the healthcare industry, aimed at improving patient outcomes, enhancing care quality, and reducing healthcare costs. Unlike traditional fee-for-service models, which reimburse healthcare providers based on the quantity of care services delivered, VBC focuses on rewarding providers for the quality and effectiveness of care they provide to their patients. This model aligns financial incentives with patient outcomes, encouraging healthcare providers to offer care that is both efficient and tailored to the individual needs of patients.

The impact of VBC on the healthcare ecosystem is multifaceted. Firstly, it prompts a shift in the focus of healthcare delivery from treatment to prevention and patient wellness. By incentivizing positive patient outcomes, VBC encourages providers to invest more in preventive care measures, chronic disease management, and holistic approaches to patient health. This can lead to a decrease in hospital readmissions, fewer unnecessary medical procedures, and overall, a more sustainable healthcare system.

Secondly, VBC fosters collaboration among healthcare providers. Since the model rewards the improvement of patient outcomes across the continuum of care, it encourages different providers to work together more closely. Hospitals, primary care physicians, specialists, and even non-medical support services are motivated to share information and coordinate care more effectively, ensuring that patients receive the right care at the right time.

Patient-Reported Outcomes (PROs) play a crucial role in the success of VBC programs. PROs are direct reports from patients about how they feel in relation to a health condition and its therapy, without interpretation of the patient’s response by a clinician or anyone else.

This information is invaluable because it provides insights into the patient’s perspective on their health status, quality of life, and the effectiveness of treatments.

In the context of VBC, PROs help to ensure that care delivery is genuinely patient-centered, enabling healthcare providers to tailor their interventions to meet the specific needs and preferences of each patient.

PROs contribute to the measurement and assessment of healthcare outcomes, which is central to VBC. By incorporating PROs into their assessment criteria, VBC programs can use this data to evaluate the effectiveness of care from the patient’s viewpoint. This ensures that healthcare interventions not only achieve clinical objectives but also improve the quality of life for patients. Consequently, PROs are essential for the continuous improvement of healthcare services, guiding providers towards interventions that offer the greatest benefit to patients’ health and well-being.

PROs in Clinical Trials

When life sciences companies present data from clinical trials that include PROs, they provide a more comprehensive picture of a product’s benefits. This evidence is particularly persuasive to payers and healthcare providers, who are increasingly looking for treatments that offer meaningful improvements in patients’ lives, not just clinical metrics. For payers, such information supports decision-making related to coverage and reimbursement, as it aligns with the shift towards outcomes-based reimbursement models. Products that demonstrate a positive impact on patients’ quality of life are more likely to be covered and recommended within these frameworks, ensuring broader access for patients.

Similarly, healthcare providers, who are integral to the VBC ecosystem, are more likely to prescribe products that have been shown to enhance patient outcomes and satisfaction. In the context of outcomes-based care, providers are rewarded for delivering high-quality, patient-centered care, which includes prescribing treatments that patients are more likely to adhere to because of their favorable impact on quality of life. Therefore, clinical trial data enriched with PROs can significantly influence prescribing behaviors by highlighting the patient-perceived benefits of a treatment.

The inclusion of PROs in clinical trials signals to both payers and providers that a life sciences company is committed to understanding and addressing the holistic needs of patients. This can strengthen the company’s position in negotiations with payers and foster trust among healthcare providers, facilitating the successful adoption of new products.

PROs bridge the gap between clinical efficacy and patient experience, enabling life sciences companies to better meet the demands of the evolving healthcare landscape where the patient’s voice is increasingly central to care decisions.

Leveraging PROs in clinical trials is not just about enhancing the evidence base for new medical products; it’s about aligning these products with the fundamental principles of VBC and ensuring they meet the real-world needs of patients, payers, and providers. In doing so, life sciences companies can enhance the marketability of their products, ensuring they are well-positioned for successful adoption, coverage, and use in a healthcare environment that values and rewards meaningful improvements in patient health and quality of life.

For more information, follow us on LinkedIn: Castor | Kristen Harnack

Learn more about Castor’s eCOA / ePRO

References:

  1. CMS (Centers for Medicare & Medicaid Services). “Value-Based Programs.” [CMS website]
  2. Health Affairs. “Value-Based Care and Population Health: Opportunities and Challenges.”
  3. HHS (Department of Health & Human Services). “About the Affordable Care Act.” [HHS website]
  4. FDA (Food and Drug Administration). “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.” [FDA website]
  5. Journal of Managed Care & Specialty Pharmacy. “Patient-Reported Outcomes in Performance Measurement.”

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