Watch this collaborative webinar to learn about Vulcan’s UDP (Utilizing the Digital Protocol)—a project accelerating ICH M11 and end-user value. You can access previous webinars in the series here.
Slides can be viewed 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.
During this webinar, our panelists:
- Provide a brief overview of the UDP project, including how it complements ICH M11 and TransCelerate/CDISC USDM (Unified Study Definition Model)
- Highlight the progress towards Vulcan’s publication of an implementation guide (IG), including:
- Timelines, current status and planned content – what can you expect in the IG
- Read-out from the May 2025 connectathon and how this supports the IG
- A look inside the HL7 process and how you can participate
- Discuss practical steps to prepare for implementation
Panelists:
- Hugh Glover, UDP Technical Lead, Vulcan
- Mary Lynn Mercado, Global Head Protocol Delivery & US Site Head, Regulatory Writing & Submissions, Novartis
- Stacy Tegan, Program Director, TransCelerate
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 managers, innovation managers, infrastructure managers, programmers in clinical development
- Health Authorities: clinical trial regulators, regulatory submission review (i.e., FDA and EMA)