Watch this collaborative webinar to learn about Vulcan’s Utilizing the Digital Protocol (UDP), an umbrella project accelerating ICH M11 and end-user value. This is the third webinar in the series. You can access the first and second webinars here.
If you are new to Vulcan UDP:
Check out this overview video for a comprehensive background to the Vulcan UDP project and a summary of our progress.
Slides can be viewed here. Webinar can be watched here.
During this webinar, our panelists will:
- Give you insight into the UDP Connectathons—technical events that test development work within business processes.
- Discuss the Schedule of Activities (SoA) as tested during the January 2025 Connectathon, demonstrating the ability to transmit using the SoA message and render on a receiving system as a SoA table (as seen in the protocol document).
- Address the pathway to further digitization and the impact on business processes.
Panelists:
- Hugh Glover, Technical Director, Vulcan
- Mary Lynn Mercado, Global Head Protocol Delivery & US Site Head, Regulatory Writing & Submissions, Novartis
- Dave Iberson-Hurst, USDM Product Owner, CDISC
- Chris Decker, President and CEO, 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)