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EU clinical trial regulations are changing - are you ready?

Companies and organisations conducting clinical trials in the EU are about to see the largest shake up of legislation for decades, with the introduction of the EU-Clinical Trials regulation (EU-CTR).

The new regulation is being brought in to simplify and harmonise the regulatory environment for clinical trials carried out in Europe; resulting in reduced administrative burdens for sponsors. The goal is to simplify and unify processes across the European Union, which should mean sponsors will see cost savings, reduced delays and better trial outcomes.

This article reviews the latest timelines for the introduction of the EU-CTR and outlines the most significant changes that this new regulation will bring to the operation of clinical trials in Europe.

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