New EU Clinical Trial System Has Implications For Wider Study Operations
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.
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When the new Clinical Trial Information System goes live at the end of January, it will usher in many practical and operational considerations that sponsors need to be aware of.
A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.
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.