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
- Solution Providers that utilize clinical protocol information, such as:
- 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.