EU Clinical Trial Portal Requires Rethink On Balancing Business Interests & Transparency
Sponsors Can Defer Publication Of Certain Data
In the first of a two-part article on transparency provisions for the new EU clinical trial portal, the Pink Sheet reports on aspects that sponsors must consider to protect commercially confidential information in their clinical trial applications. The second article will look at the approach taken by Merck and discuss outstanding hot topics in relation to transparency and CTIS.
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The European Medicines Agency’s management board believes it is time to review the disclosure rules under the EU Clinical Trial Regulation that were agreed almost seven years ago.
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.
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.