Transitioning Trials to the EU Clinical Trials Regulation

The transition from the EU Clinical Trials Directive (CTD) to the new Clinical Trials Regulation (CTR) represents a major shift in how trials will be conducted across Europe. While this overhaul aims to streamline processes, navigating EU CTR is complex. We have distilled recommendations from the EU Clinical Trials Coordination and Advisory Group (CTAG) into actionable checklists to aid in planning, and our proposed workflow highlights steps to help sponsors navigate the transition process.

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