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Challenges Persist in EU Clinical Trials Regulation Rollout

 
• By Vibha Sharma

EU regulators say they have tackled many of the concerns raised by study sponsors in two surveys regarding the implementation of the EU Clinical Trials Regulation and are now focused on addressing the five “most critical remaining challenges.”

Wide view image of male hand drawing silhouette of a man making a stop gesture to prevent wooden dominos from collapsing. Over navy blue background.
Improvements To CTIS Can Help Address Ongoing Issues With The CTR • Source: Shutterstock

Study sponsors who participated in a second survey on the implementation of the EU Clinical Trials Regulation (CTR) late last year reported disappointing progress on resolving the majority of the issues raised by them in an initial survey in 2022.

The second CTR implementation survey was undertaken by EU regulators from 6 September until 4 October 2023 to evaluate whether...

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