Transitioning Clinical Studies from Traditional to Decentralized: An Operational and Regulatory Perspective


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Given the unprecedented global health situation, we are seeing a swift change in attitude towards Decentralized Clinical Trials (DCTs) – both fully virtual and hybrid approaches. This is particularly true from a regulatory perspective, where new guidance is coming out with a number of agencies proactively stating their preference for a DCT approach to support patients.

In this webinar, Parexel experts will explore what these changes mean for ongoing traditional trials including:

  • Evaluating which trials are suitable to decentralize and implementing critical operational processes for the conversion
  • Emerging regulatory guidance related to operating in a COVID-19 world and what that means for DCTs
  • Design of the Quality Management System
  • Risk-based approaches to clinical e-system and data privacy compliance

Sponsored by: Parexel

Roz Round, Vice President, Patient Innovation Center, Parexel
Felicia Ford-Rice, Director, Strategic Compliance, Parexel