Using Decentralized Trial Technology to Ensure Study Continuity and Data Quality During COVID-19 and Beyond

July 9th, 2020 by

The COVID-19 pandemic has necessitated rapid digitization of everyday activities across the world, and the clinical research industry is no exception. Research organizations have accelerated plans for digital transformation from years to months to weeks. Adopting decentralized methods in this space is not an option; it’s now a requirement for normal operations.

As part of the research industry’s pandemic response, decentralized and hybrid trials are garnering much attention. Download this white paper to learn the following:


In this white paper, we’ll also discuss how a patient-centric approach positively influences the success of studies. With appropriate technology, participants can engage in research from the comfort of their own homes. By easing burdens such as travel for site visits, removing geographic and logistical constraints to participation, and using electronic data capture, sponsors benefit from the following:

 

The Impact of ISO 14155 on PMCF Investigations Under the MDR

June 25th, 2020 by

Through the Medical Device Regulation (MDR) and new version of ISO 14155, the regulatory landscape for clinical investigations with medical devices will significantly change. In contrast with previous regulations, all Post-Market Clinical Follow-up (PMCF) clinical investigations will have to be conducted in compliance with the ISO 14155 standard. Although some PMCF investigations may be exempted from a number of requirements, the basic necessities remain applicable, such as implementing written quality procedures, monitoring and document management.

The MDR specifies that clinical investigations should be in line with ISO 14155:2011 on good clinical practice (MDR (64): p. 9) and that sponsors should provide evidence that clinical investigations are conducted in line with good clinical practice (MDR Annex XV Chapter III Point 6: p. 172). In addition, under the MDR both pre- and post-market clinical studies count as a clinical investigation, which extends the requirement to comply with good clinical practice to post-market trials, both interventional and observational types.

In addition, Annex I of the new ISO 14155 describes the clinical development stages of medical devices, including the applicability of the standard to every specific stage. For post-market observational studies, possible exemptions are indicated for device accountability, labeling for clinical investigations, need for an Investigator Brochure, reporting to regulatory authorities, full informed consent, and CVs of members of the investigation site team.

Although the COVID-19 pandemic has delayed the implementation date, now is still the time to prepare for compliance with this updated set of regulations. In this white paper, we discuss how the following will be impacted:


Prepare your organization for the MDR and ISO14155 updates with this white paper. Fill out the form below to download your copy!

 

Satisfying PMCF requirements by utilizing IIS data

February 4th, 2020 by

It has been estimated that 85% of the millions of dollars spent on clinical research fails to be useful; however, there is an increasing mandate for clinical data to help inform meaningful, pragmatic approaches to disease management. The costs associated with conducting clinical trials to generate new insights is often too high when compared to the slim returns, especially in terms of quality of the clinical data collected (Ioannidis J 2016). Yet maximizing the quality and variety of clinical data collection is a medical necessity, and a desirable business objective. 

In general, the medical device industry spends hundreds of millions on Investigator Initiated Studies (IIS) or External Research Programs (ERP) each year, but there is limited quality control, monitoring and/or reuse of data generated in these studies.

To help resolve these challenges we propose a solution in which data generated through IIS will be of higher quality and should satisfy regulatory requirements for medical research such as those outlined in GCP and the MDR. Furthermore, our solution can maximize the impact of these IIS data for the investigator through successful scientific publications, and the sponsor through real-time progress reports and reuse of anonymous study data.

This white paper describes an approach that would enable medical device manufacturers to leverage anonymous data from IIS projects to support the fulfilment of PMCF data requirements.

Download your copy of the white paper by filling out the form below.

 

5 steps to meet PMCF requirements

January 31st, 2020 by

Under the MDR, manufacturers are mandated to routinely collect and evaluate data on their high-risk CE-marked devices with PMCF activities. Although these activities can be costly, PMCF processes can be optimized.

With Castor, manufacturers can create and execute PMCF activities smoothly and effectively in just 5 steps. A user-friendly interface guides users to determine PMCF design –by indicating endpoints and whether the data are submitted by a HCP or patients, and whether data are collected prospectively or retrospectively. With this step, forms are automatically generated.

Next, Castor’s interface guides users to define enrollment strategy and then validate the model and forms created. Once PMCF activities have been launched, users can track progress all along, and finally extract the data into charts to be used in reports and submissions.

Read the white paper to learn how Castor’s 5-step approach to PMCF can be used to fulfill MDR requirements.

Download your copy by filling out the form below.

 

6 essential steps to ensure Medical Device Regulation (MDR) compliance before May 2020

September 19th, 2019 by

The impact of the Medical Device Regulation on the medical device industry is substantial as the regulations focus on the complete product lifecycle from device development to post-market surveillance. More importantly, the MDR aims to improve patient safety by making it easier to identify any issues with medical devices in the market. Although the MDR is a step in the right direction, it is going to be immensely challenging for smaller companies to comply with it.

A recent report surveying representatives from the medical device industry across the globe said that more than 75% claimed only a basic understanding of how to prepare for MDR compliance. Furthermore, running full clinical trials, resubmission, and setting up post-market surveillance will be an enormous challenge.

With less than 9 months, the time to act is now. This white paper provides 6 practical steps that every medical device company needs to take to ensure MDR compliance by May 2020. Here’s a quick preview of the 6 steps:  

Step 1: Which devices will stay or go? 
Step 2: Do you have the right clinical data?
Step 3: Are you talking to the right notified bodies?
Step 4: Confirm timeline with your notified body
Step 5: Apply on time
Step 6: Apply for a 4-year extension—But be careful (Optional)

Download your copy of the White Paper by filling out the form below.

 

Three expected changes to FDA medical device approval in 2019

February 11th, 2019 by

2019 was an interesting year for medical device companies. In our previous blog articles, we discussed the complete overhaul of medical device regulations in Europe. The EU MDR is set to come into effect in May 2020, and the industry is also facing impactful changes across the pond.

At the end of 2018, the FDA announced several upcoming changes to the way medical devices are approved in the United States. With no signs that these changes will be delayed, it’s just a matter of time before the FDA provides updated guidelines and requirements.

In this White Paper, we will discuss three expected changes to the FDA medical device approval process. In particular, we will discuss:

1) the proposed revision to the 510(k) process;

2) the proposed new rules on the de novo pathway; and

3) the changes in the way e-health technologies will be evaluated

Download your copy of the White Paper by filling out the form below.

In-Vitro Diagnostic Regulation (IVDR): From oversight to overhead

September 11th, 2018 by

The rising demand for early, accurate disease diagnosis and the growing possibilities in personalised medicine are driving the demand for In-Vitro Diagnostic medical devices (IVDs). Thermometers, blood glucose monitoring devices and pregnancy tests, are an integral part of our lives.

IVDs have traditionally been subject to little regulation when compared to medical devices or pharmaceuticals. The new In-Vitro Diagnostic Regulation (IVDR), however, will constitute a true quantum leap in regulatory burden. This white paper we will focus on the IVDR and how IVD companies can meet these regulatory changes. We will cover:

Download your copy of the White Paper by filling out the form below.

What does the Medical Device Regulation (MDR) tell us about Post-Market Surveillance?

August 7th, 2018 by

With the Medical Device Regulation (MDR) coming into full force in 2020, medical device companies should prepare for tougher Post-Market Surveillance (PMS) requirements. Companies will need to update their PMS procedures and should budget for more Post-Market Clinical Follow-up (PMCF) studies.

This article will address the role of Post-Market Surveillance during the lifecycle of your device, the specific requirements for Post-Market Surveillance under the MDR, and how an EDC system can help you fulfill these requirements in a cost-effective way. We will cover:

1) the role of Post-Market Surveillance during the lifecycle of your device;

2) the specific requirements for Post-Market Surveillance under the MDR;

3) how an Electronic Data Capture (EDC) system can help you fulfill these requirements in a cost-effective way.

Download your copy of the White Paper by filling out the form below.

4 ways the Medical Device Regulation (MDR) will impact your device studies

June 26th, 2018 by

Medical device companies targeting the EU market are being confronted with significant regulatory changes for market access. As of May 25th 2017, the Medical Device Regulation (MDR) has replaced the long-standing Medical Device Directive (MDD). The impact of the Medical Device Regulation to the medical device industry is substantial as it requires the re-classification and re-registration of all medical devices currently on the market.

Moreover, the Medical Device Regulation outlines new clinical data requirements for (maintaining) certification of medical devices. Besides requiring more clinical data collection throughout the product’s lifecycle, it also raises the bar for the level of evidence that is required.

What does this mean for your company? In this white paper we will discuss four ways in which the Medical Device Regulation will impact your clinical study requirements, and we will provide links to useful resources. In particular, we will discuss that:

1. More medical devices will require clinical investigation;

2. Equivalence will be harder to demonstrate;

3. The level of evidence required for medical device studies will be higher;

4. There will be more focus on post-market surveillance (PMS).

We will further discuss how to best process this new clinical data in a way that is compliant and cost-effective, using an electronic data capture (EDC) system.

Download your copy of the White Paper by filling out the form below.

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