How Merck Plans To Protect Commercial Info Under EU Clinical Trial Rules
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.
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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.
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.
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.