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Navigating the Changes to the EU Clinical Trials Regulations 536/2014 – Managing the Application and Authorisation Process
Insights, THREAD Leslie Yates Insights, THREAD Leslie Yates

Navigating the Changes to the EU Clinical Trials Regulations 536/2014 – Managing the Application and Authorisation Process

The processes for applying for and authorizing clinical trials in Europe have, traditionally, held numerous inefficiencies. Currently governed under the Clinical Trial Directive 2001/20/EC, trial sponsors have been required to submit separate applications for each member state in the European Economic Area (EEA) where they planned to conduct a study.

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3 Ways that Technology Can Help Make Clinical Trials More Representative
Insights, THREAD Leslie Yates Insights, THREAD Leslie Yates

3 Ways that Technology Can Help Make Clinical Trials More Representative

Representation in clinical trials is a hot topic. The historical lack of representativeness and diversity in research came to greater attention recently as the world raced to develop safe vaccines that would work for everyone. Healthcare and political leaders needed to ensure that they could say with confidence that the resulting vaccines would work for everyone…

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