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Vulcan UDP (Utilizing the Digital Protocol): Spotlight on Connectathon Results and Plans

 

Event Date: Tuesday, 15 October 2024

Event Time: 9:00 to 10:30 a.m. EST

 

Following the success of the first webinar, we're excited to announce the second in the series! Join us to learn about Vulcan’s Utilizing the Digital Protocol (UDP), an umbrella project accelerating ICH M11 and end-user value. The protocol agreed upon between the sponsor and regulator governs all aspects of a clinical trial. ICH M11/M2, CDISC, and TransCelerate are working toward a digital form of the protocol. Vulcan UDP is bringing those components together into an FHIR-based exchange to ensure the protocol's interoperability across stakeholders.

During this webinar, our panelists will:

    • Provide a brief background of the UDP project, with additional details available in the July webinar recording.
    • Give you insight into the UDP Connectathons—technical events that test development work within business processes. The focus will be on study-level elements of the title page, eligibility criteria, objectives/endpoints/estimands, and opportunities to participate in future Connectathons.   
    • Discuss the practical steps to prepare for implementation.  

Panelists:

  • Hugh Glover, Technical Director, Vulcan
  • Vivian Combs, Executive Director of Clinical Trial Foundations, Eli Lilly
  • Chris Decker, President and CEO, CDISC
  • Dave Iberson-Hurst, USDM Product Owner, CDISC

Ideal Attendees: ​

  • Anyone interested in Clinical Data Interoperability 
    • Solution Providers that utilize clinical protocol information, such as:
      • Study builders and authoring platforms 
      • Structured content management tools 
  • Sponsors and CROs involved in processes that consume protocol information, such as:
    • Protocol and Development Authoring  
    • Clinical Trial Digital and Technology Support 
    • Regulatory Operations, submissions & document management 
    • Data Manager; Innovation Manager, Infrastructure Manager, Programmers in Clinical Development
  • Health Authorities: clinical trial regulators, regulatory submission review (i.e., FDA and EMA)
     

TransCelerate webinars may be recorded in whole or in part.