New FDA Draft Guidance Shows That the Time for Decentralized Clinical Trials is Now
On May 1, 2023, the U.S. Food and Drug Administration (FDA) released an updated Draft Guidance on decentralized trials, providing recommendations for clinical trial sponsors as they incorporate virtual elements into their programs.
The FDA recognizes that decentralized clinical trials offer significant benefits, but they also require careful planning and coordination in the lead-up to and throughout trial execution.
Are you prepared for what's to come? Download the insight brief to learn more.
Transform Observational Studies with a Virtual Site
Are your observational or long-term follow-up studies facing challenges? Are keeping protocols open across multiple sites slowing down your studies? Or is loss of participant involvement causing delays?
Imagine if you could collect real world evidence anywhere—regardless of location.
At Science 37, our Metasite (virtual site) is paving a new path with decentralized/hybrid long-term follow-up studies by delivering a model that follows the patient—improving patient experience and retention while enabling long-term data capture.
Download our insight brief to learn about how to transform your RWE studies.
How to Save an At-Risk Clinical Trial
How can you rescue an at-risk clinical trial without compromising quality? Delays in clinical research are common and cost pharmaceutical companies exorbitant amounts of money. Four in five clinical trials experience delays, with 94% of trials delayed more than a month—creating a potential financial impact of more than $600,000 daily.1
In this insight brief, Science 37 Chief Delivery Officer, Darcy Forman details how a virtual site (Metasite) is the premier strategy for rescuing an at-risk clinical trial- resulting in faster recruitment and streamlined operations.
1 Article from Drug Development & Drug delivery https://drug-dev.com/cost-of-disrupted-clinical-research-due-to-covid-19-equates-to-10-billion-potential-study-delays/
Why Migraine and Other Headache Disorders Are a Good Fit for Decentralized Clinical Trials
Characterized by recurring episodes of moderate to severe headache, elevated sensitivity to sound and/or light and other unpleasant symptoms, migraines can often be debilitating for the roughly 35 million people in the U.S. who suffer from this condition.
The current model for clinical research in migraine may fail to accurately capture the whole effect this disorder has on persons with migraine. In his latest insight brief, Dr. David Kudrow, M.D. explains how decentralized clinical trial (DCT) technologies can help to improve the patient experience from enrollment through trial completion — with numerous benefits to sponsors and research organizations as well.
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