UK Explains How To Build COVID-19 Resilience Into Trial Design
Sponsors Can Use Existing Regulatory Flexibilities To Minimize Further Disruptions
The UK Medicines and Healthcare products Regulatory Agency wants clinical trial sponsors to integrate available regulatory flexibilities into normal practice so that their studies can withstand further potential disruptions from the COVID-19 pandemic.
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The UK’s Medicines and Healthcare products Regulatory Agency says that any increase in clinical trial protocol deviations in relation to coronavirus outbreak will not constitute a serious breach.
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.
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.