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New EU Clinical Trial System Has Implications For Wider Study Operations

 
• By Vibha Sharma

Companies readying themselves for the upcoming implementation of the EU Clinical Trial Regulation should think beyond its obvious stated aim of harmonizing the submission and evaluation of trial applications. The regulation, which will be implemented via a new portal, has the potential to affect several business dimensions.

Clinical trial
EU CT Portal Will Result In Major Changes To Clinical Trial Conduct • Source: Shutterstock

The European Medicines Agency’s new Clinical Trial Information System (CTIS) may be an EU-centric tool designed to implement specific provisions of the EU Clinical Trial Regulation, but companies should be mindful of the combined impact of these provisions on their overall study operations.

The CTR – and its implementation via the CTIS portal – will not just affect company processes relating to the submission of clinical trial dossiers in the EU. It will...

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