4 Implications of the EU's New Clinical Trial Regulation

The Changing EU Clinical Trial Landscape

May 27, 2014 was a pivotal day for clinical trials in the European Union (EU). On this date, the EU Clinical Trial Regulation (No. 536/2014) was officially published, replacing EU directive No. 2001/20/EC and revamping the way clinical trials are conducted in the region. For international trial sponsors as well as National Competent Authorities and EU member states, this regulation is a game-changer.

The new regulation harmonizes clinical trial requirements throughout the EU by establishing a new Clinical Trials Information System—a centralized portal and database developed and maintained by the European Medicines Agency (EMA) in collaboration with the European Commission and EU member states. Part of the information system will be open to the public subject to new transparency rules.

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Portal Creates Significant Challenges for Trial Sponsors

In our new whitepaper, we examine the upcoming regulation's impact on the clinical trial process for trial sponsors around the globe.

In this paper, you'll learn:

• How a new, centralized EU portal for clinical trials affects trial submissions and authorizations.


• How to establish efficient and reliable content translation in a region with 24 different official languages.


• How to respond to an increased drive for transparency, which puts the public and the patient in focus.


• How trial sponsors can meet challenges head-on with a centralized translation strategy.

Ready to learn more? Download the paper today.