Six top tips to prepare for the new EU Clinical Trial Regulation
The European Union Clinical Trial Regulation 536/2014 (EU-CTR) aims to standardize and harmonize the conduct and management of interventional clinical trials across the European Economic Area (EEA), with legally binding rules on requirements and increased transparency. The new EU-CTR promises a simplified process designed to decrease the burden resulting from idiosyncratic interpretations of the current EU-CTD. But to reap efficiencies, sponsors must sow operational changes. This article covers the six essential preparations companies should undertake now.
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