FDA's Draft Guidance on Data Integrity for Bioavailability & Bioequivalence Studies, Sanofi's DCT Definition, and More
Clinical Leader
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Welcome to the Clinical Trial Insights newsletter, featuring strategic insights and expert opinions on designing and running clinical trials. Each edition covers the latest trending articles on ClinicalLeader.com.
In this week's issue, we'll explore the FDA's new draft guidance on maintaining data integrity throughout bioavailability/bioequivalence studies, what defines a DCT at Sanofi, how Regeneron's Digital Biomarkers Summit is bringing competitors together, what to consider when selecting an RTSM vendor, and other popular insights.
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WEBINAR 06.11.24
Efficient Trials For Optimal Outcomes: Balancing Data, Technology, and Strategy in Clinical Research
In this webinar, Medrio CEO Nicole DuPont Latimer and Blue Parachute Group Founder & CEO Amy Longcore will uncover common pitfalls in trial data management, such as collecting insufficient or irrelevant data, and explore best practices for an effective data collection strategy and how to select technology to support your research needs.
TOP 5 READS OF THE PAST WEEK
The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.
In this snippet from Clinical Leader Live, Merissa Govender , Global Innovation Leader at Sanofi , explains how the company defines a DCT and what therapeutic areas they focus on for these kinds of trials.
领英推荐
The pharma industry isn’t known for collaboration, but Regeneron is trying to change that — at least as far as digital biomarkers are concerned. Chief Editor Dan Schell caught up with Rinol Alaj to learn more about why Regeneron is producing their Digital Biomarkers Summit.
Keep these insights in mind when choosing an RTSM technology and vendor to ensure both your technology aligns with your business's growth and your partner is committed to your success.
To commemorate Clinical Trials Day 2024, Clinical Leader's Abby Proch tapped our community of clinical research professionals to share their insights — from individual efforts to partnership best practices to trial design and more.
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