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Session 5: Operational Challenges and Best Practices in Implementing Innovative Clinical Trials
Session Chair(s)
Veronica Bubb, DBA, PHD, MS
Vice President of Operations
Advance Research Associates, Inc., United States
Amy Burd, PHD
Chief Scientific Officer
Eilean Therapeutics, United States
Through insights gained from the process of operationalizing master protocols, these studies provide a roadmap for implementing innovative clinical trial designs. The challenges and best practices in implementation begin with documentation and continue through the operationalization of complex clinical trials. The session will review challenges, best practices, and discuss tools available to manage innovative trial designs based on recent master protocol trials.
Learning Objective : At the conclusion of this session, participants should be able to:
- Share a roadmap for the documentation and operationalization of innovative clinical trials
- Discuss operational challenges and provide an explanation of available tools
- Present suggested best practices and lessons learned for the future trial development
Speaker(s)
Addressing Health Literacy in the Context of Clinical Trials
Michael S. Wolf, PHD, MA, MPH
Institute for Public Health and Medicine, United States
Professor, Medicine, Northwestern Medicine; Associate Vice Chair for Research
Operational Challenges and Best Practices in Implementing Innovative Clinical Trials
Hugh Levaux, PHD
Flatiron Health, United States
Vice President, Growth Strategy for Clinical Research
Operational Challenges and Best Practices in Implementing Innovative Clinical Trials
James Denmark
myClin, United States
Founder & CEO
Operational Challenges and Best Practices in Implementing Innovative Clinical Trials
Trang Gisler, MS, PMP
PPD, part of ThermoFisher, United States
Senior Director, Government and Public Health Services