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Transforming the Protocol from a Document-Centric to a Data-Centric World Enabling Study Execution Automation and Regulatory Review
Session Chair(s)
Chris Decker, MS
President and CEO
CDISC, United States
Come learn about the exciting world of digital protocol and how industry innovators are taking the steps to transition from a document-centric protocol to a data-centric protocol, how digital protocol use cases can be enabled by AI and listen to how you and your company can prepare for the change required to adopt digital protocol. We will start with an update on current initiatives including the TransCelerate Digital Data Flow (DDF), CDISC Unified Study Definition Model (USDM), and ICH M11 Harmonized Protocol. Then we will explore the opportunities industry has to leverage structured digital protocol information to enable AI supporting innovation such as intelligent study design, automation of data transformation and analysis, and dynamic regulatory review. Finally, we will share our thoughts on how you and your company can get started on the digital protocol journey.
Learning Objective : Understand how various digital protocol collaborations are working together including ICH M11, TransCelerate/CDISC Digital Data Flow, and the HL7 Vulcan Unified Digital Protocol; Learn about possible AI use cases that can leverage standard digital protocol information; Prepare for the implementation and change management required to realize the benefits of a digital protocol.
Speaker(s)
Preparing for ICH M11 and Digitial Protocol: Am I Prepared?
William Illis, MPH
Novartis , United States
Global Head, Collaboration/Technology Strategy, Clinical Development & Analytics
Industry Initiative Updates: How TransCelerate DDF, CDISC, USDM, and ICH M11 are Transforming Industry
Chris Decker, MS
CDISC, United States
President and CEO
Opportunities for Digital Protocol Standards Can Enable AI
Robert DiCicco, PharmD
TransCelerate Biopharma Inc., United States
Vice President, Portfolio Management
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