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AKRN handles mid-study changes in medical device clinical trials with Castor EDC
AKRN Scientific Consulting, a medical device CRO, used Castor's flexible EDC solution to handle constant mid-study changes for...
Automated data capture with eSource to train an AI algorithm
Castor’s eSource platform streamlined collecting, capturing & processing large amounts of clinical data to train AusculThing’s AI algorithm.
COVID-Red: Evaluating wearables for early remote COVID-19 detection & monitoring
When the pandemic hit, Julius Clinical was passionate to help in the global fight against COVID-19 and excited...
How to Incorporate Remote Technology in Your Next Medical Device Trial
Researchers are looking to incorporate remote technologies into medical device trials for a wide range of device classifications....
The Ultimate Guide to Post-Market Surveillance: What You Need to Know
In today’s rapidly evolving regulatory landscape, ensuring medical device safety and performance goes beyond the approval phase. Effective...
PMCF & RWE: Roles of Medical Device Registry Studies & ePROs
Registry studies focused on a specific medical device are a valuable tool to capture the safety and outcomes...
UKCA Mark: 7 Steps to Prepare Medical Devices for Brexit
In the wake of Brexit, medical device companies secure a UKCA mark as proof of conformity to place...
Common shortcomings of clinical research data for PMCF
The following is an excerpt from our free whitepaper ‘Satisfying PMCF requirements by utilizing IIS data’. Click here...
5 Ways to Leverage Castor’s API for Better Clinical Trials
eClinical systems must be flexible and adaptable to keep up with the ever-changing demands of modern clinical trials....
What Will Trial Enrollment & Engagement Look Like in a Socially-Distanced World?
When the COVID-19 pandemic began, the industry needed to focus immediately on research continuity and determine how to...
Jumpstart Your Medical Device Preclinical Phase
The path to market for medical devices can be fraught with obstacles. One of the first challenges confronted...
Protocol Deviations in Clinical Trials: Understanding the FDA’s Guidance
Protocol deviations can seriously impact the integrity of clinical trials, and with regulatory scrutiny growing, it’s crucial to...
Impact of ISO 14155 on PMCF Investigations Under the MDR
Through the Medical Device Regulation (MDR) and new version of ISO 14155, the regulatory landscape for clinical investigations with...
Impact of COVID-19 and the Imminent MDR Delay
Introduction The implementation of the new EU Medical Device Regulation (MDR) just got a plot twist: COVID-19. This...
Forecasting the impact of COVID-19 on medical device trials
As of early April 2020, over 1,000,000 people have been confirmed infected with the SARS-CoV-2 coronavirus, and governments...
6 Steps for Using eCOA / ePRO & Physician Surveys to Fulfill MDR PMCF
To ensure ongoing regulatory compliance under the EU MDR, medical device manufacturers must demonstrate the safety and performance...
4 reasons why having a single EDC system for your device company makes sense
CEOs of medical device companies have an intuitive sense of what they need from their clinical data. However,...
