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Transforming the Protocol from a Document-Centric to a Data-Centric World Enabling Study Execution Efficiencies and Regulatory Review
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Basic

This session will provide an update on recent industry initiatives to transform towards a data-centric protocol, demonstrate real use cases leveraging digital protocol information, and share thoughts on how to prepare for the change required.

Learning Objectives

Understand how various digital protocol collaborations are working together including ICH M11, Transcelerate/CDISC Digital Data Flow, and the HL7 Vulcan Unified Digital Protocol; Demonstrate the digital protocol in action from design through regulatory review; Prepare for the implementation and change management required to realize the benefits of a digital protocol.

Chair

Chris Decker, MS

Speaker

Transforming the Study Protocol from a Document-Centric to a Data-Centric World to Enable AI, Drive Automation, and Design Be
Chris Decker, MS

Preparing for ICH M11: Am I Prepared?
Robert DiCicco, PharmD


Speakers
avatar for Chris Decker

Chris Decker

President and Chief Executive Officer, CDISC, United States
Chris is recognized industry wide as a leading technology and standards expert for designing, developing, and implementing complex process and technology solutions. He brings years of experience serving in various executive-level positions across software development, clinical research... Read More →
avatar for Robert DiCicco

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. Rob joined TransCelerate from IBM Watson Health where he was the Deputy Chief Health Officer. At IBM he worked closely with software designers and developers to inform product roadmaps. Rob also... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

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