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Session 1 Track 3 - Mission Possible: How TransCelerate is Improving the Protocol Template and Paving the way for the Digital Protocol
Session Chair(s)
Stacy Tegan
Program Director
Transcelerate Biopharma, Inc., United States
TransCelerate BioPharma, a non-profit consortium of over 20 sponsor companies, is tackling some of the biggest challenges in the clinical development process. The Common Protocol Template, and a implementation communications toolset, is now available to anyone via the TransCelerate website. Learn how this protocol template brings value today and sets the stage for enabling trial registry disclosure, downstream automation, and end-to-end traceability.
Speaker(s)
FDA Perspective of the Protocol Template
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
The Common Protocol Template: Common Structure, Common Language, Uncommon Benefits to End Users
Robert DiCicco, PharmD
TransCelerate Biopharma Inc., United States
Vice President, Portfolio Management
The Common Protocol Template: Foundation for the Future
Robert L. Ferendo
Eli Lilly and Company, United States
Consultant-Process & Technology
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