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Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Principal Consultant
Decision Analytics, United States
The session explores the transformative impact of the ICH M11 digital protocol template on key clinical trial stakeholders, such as medical writers, standards professionals, and regulatory reviewers. It highlights how standardized, structured content
Learning Objective : Recognize the ICH M11’s Role in Digital Protocols Across Stakeholder Roles; Explain Customization and Multi-View Capabilities; Discuss how to evaluate the Impact on Decision-Making and Efficiency for Key Roles; Describe ways to examine Multi-Format Exchange of Protocol Information.
Speaker(s)
Digital Protocol Template: Industry Perspective
Vivian Combs, MS
Eli Lilly and Company, United States
Executive Director, Clinical Trial Foundations
Digital Protocol Template: Regulatory Perspective
Y. Veronica Pei, MD, MEd, MPH
FDA, United States
Lead Physician, Associate Director, Biomedical Informatics and Regulatory Review
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