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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)
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, United States
FDA Perspective of the Protocol Template
Robert DiCicco, PHARMD
Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
The Common Protocol Template: Common Structure, Common Language, Uncommon Benefits to End Users
Robert L. Ferendo
Consultant-Process & Technology, Eli Lilly and Company, United States
The Common Protocol Template: Foundation for the Future
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