Launch Of EU Clinical Trial Portal Moves A Step Closer
Key Audit To Check Full Functionality Of CT System Gets Underway
An independent audit of the new EU Clinical Trials Information System has finally commenced, indicating that plans are on track for the EU Clinical Trial Regulation to be implemented from December 2021.
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In the second segment of a two-part article on transparency provisions for the new EU clinical trial portal, a senior Merck executive explains how the company will ensure that commercially sensitive information and personal data in its clinical trial applications are not made public.
Drug companies will be able to “play around” with the new EU Clinical Trials Information System in a secure testing environment before it goes live in approximately 15 months.
Executive Summary: The European Medicines Agency’s management board has decided on December 2021 as the go-live date for the EU Clinical Trials Information System. It will also meet later this month to elect the EMA’s new executive director to succeed Guido Rasi.