Regulatory Interactions and Learnings-RADIAL the Trials@Home Proof-of-Concept Trial on Decentralization

Helga Gardarsdottir1,2,3, Hamidou Traore4, Kate Huntley5

  • 1Division Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, The Netherlands.

Summary

Early regulatory engagement is crucial for successful decentralized clinical trials. Sharing experiences can overcome legislative hurdles and advance European clinical research.

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