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Modernizing Clinical Trials Using Digitized Protocol Information: An Exploration of New Tools for Digital Transformation


Event Date: Wednesday, 13 December 2023

Event Time: 10:00 to 11:00 a.m. EST


Join us for a presentation and panel Q&A to explore the newly released resources developed by TransCelerate’s Digital Data Flow (DDF) Initiative.  DDF, in collaboration with CDISC and other industry stakeholders, has built the foundational capabilities and is helping enable a digital transformation that unlocks efficiencies in the design and conduct of clinical studies, while modernizing pharma to healthcare interoperability. 

This webinar will include:  

  • An overview of the available tools and resources from different stakeholder perspectives. 
  • Exploration of various implementation scenarios that provide optionality towards greater USDM conformance. 
  • Focused discussion on several model implementation resources that may be used as a catalyst in your digitalization journey – solutions include the Study Definitions Repository (SDR) and prototype Common Protocol Template (CPT) Utility Tool.


  • William Illis, Global Head of Collaboration & Technology Strategy, Clinical Development & Analytics, Novartis
  • Gernot Weber, Head of Data Strategy & Digital Innovation, Merck
  • Craig Galan, Director of Digital Capability Management, Solution Architecture, BMS
  • Renu Shukla, Statistical Programming TA Head Oncology, J&J
  • Michael Vesik, Senior Project Manager, Industry Collaborations, Genentech 

Ideal Attendees: 

  • Solution Providers that utilize clinical protocol information, such as:
    • Study builders and authoring platforms 
    • EDCs 
    • CTMSs and CDMSs 
    • IRTs 
    • Central laboratories 
    • EHR systems
  • Sponsors and CROs involved in processes that consume protocol information, such as:
    • Protocol and Development Authoring Community
    • Clinical Trial Operations; e.g., Study Start Up, Systems Set Ups
    • Clinical Trial Digital and Technology Support
    • Data Manager; Innovation Manager, Infrastructure Manager; Programmers in Clinical Development
    • Health Authorities

TransCelerate webinars may be recorded in whole or in part.