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Hyatt Regency Tysons Corner

2022年11月03日 (木) 午後 12:00 - 2022年11月04日 (金) 午後 8:20

7901 Tysons One Place, Tysons Corner, VA 22102

Innovative Trial Designs Conference

Innovating for Modernized Clinical Trials

Session 5: Operational Challenges and Best Practices in Implementing Innovative Clinical Trials

Session Chair(s)

Veronica  Bubb, DBA, PhD, MS

Veronica Bubb, DBA, PhD, MS

Vice President of Operations, Advance Research Associates, Inc., United States

Amy  Burd, PhD

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)

Michael S. Wolf, PhD, MA, MPH

Michael S. Wolf, PhD, MA, MPH

Professor, Medicine, Northwestern Medicine; Associate Vice Chair for Research, Institute for Public Health and Medicine, United States

Addressing Health Literacy in the Context of Clinical Trials

Hugh  Levaux, PhD

Hugh Levaux, PhD

Vice President, Growth Strategy for Clinical Research, Flatiron Health, United States

Operational Challenges and Best Practices in Implementing Innovative Clinical Trials

James  Denmark

James Denmark

Founder & CEO, myClin, United States

Operational Challenges and Best Practices in Implementing Innovative Clinical Trials

Trang  Gisler, MS, PMP

Trang Gisler, MS, PMP

Senior Director, Government and Public Health Services, PPD, part of ThermoFisher, United States

Operational Challenges and Best Practices in Implementing Innovative Clinical Trials

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