Transitioning Clinical Studies from Traditional to Decentralized: An Operational and Regulatory Perspective
Roz Round, Vice President, Patient Innovation Center, Parexel
Felicia Ford-Rice, Director, Strategic Compliance, Parexel
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
About the Sponsors
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. Headquartered near Boston, Massachusetts and in Durham, North Carolina, and supporting clients in more than 100 countries, our almost 20,000 employees are united by one simple fact. We care. We’re not just the people with brains, we’re the people with heart.For more information please visit www.parexel.com/.