A New EU Regulation Presents Challenges...and a Big Opportunity

The upcoming EU Clinical Trial Regulation (No. 536/2014) will impact the clinical trial process in myriad ways. In our new whitepaper, we dive deep into four ways the regulation will affect trial sponsors around the globe.

The primary goal of the Clinical Trial Regulation is to create a more favorable trial environment in the EU through enhanced efficiency, reduced costs and timing, and the highest standards of safety.

The Central Challenge? A Public Portal of Trial Information

Central to the new Clinical Trial Regulation is the deployment of the Clinical Trials Information System. This secure, unified portal and database will be used by trial sponsors and National Competent Authorities within each member state, and it serves as the centralized repository for all clinical trial-related information. The EMA will manage the database and supervise content publication on a public website, keeping the responsibility for trial authorization and oversight in the hands of member states.

For regulators and trial sponsors, a dedicated workspace will be available to prepare, share, and collaborate on data and documents. For the public, the portal provides access to non-confidential information on clinical trials for medicinal products conducted in the EU, in all official EU languages once the system is launched. This enables the population at large to:

• Review clinical trial statistics and download data and reports


• Read summaries of trial results in plain, non-technical language


• Conduct advanced searches of clinical trials and receive site updates

The Big Opportunity? A Centralized Translation Plan

Transitioning from the current de-centralized way of managing clinical trial submissions and authorizations to a new approach in which sponsors submit a single dossier to all member states through the centralized EU portal means trial sponsors must:

• Meet shorter review cycles and manage coordinated reviews


• Refine processes and increase transparency to reduce compliance risk


• Ensure consistent and swift translations across multiple EU languages.

In our new whitepaper, we explore how the EU portal may create significant translation challenges for trial sponsors.

Yet challenges beget opportunities, and we'll also examine how implementing a global, centralized approach to translations—as opposed to managing translations locally—can help sponsors generate rapid and reliable clinical and plain language content to address the demands of the new Clinical Trial Regulation.

Interested in learning more? Download our new whitepaper today!