“Utilizing the Digital Protocol” - Collaborating to Accelerate ICH M11 and End User Value
Join us on July 11, 9:00 – 10:30 ET, to learn about Vulcan’s Utilizing the Digital Protocol (UDP), an umbrella project that gathers multiple initiatives to develop a digital representation of a study protocol.
The session will feature a panel discussion representing the collaborative parties participating in this project. You will increase your understanding of the project’s structure, goals and objectives. Hear the intent and potential impact of M11 from the ICH M11 perspective. The session will provide a summary of the first UDP Connectathon in May and announce the upcoming Connectathon in September, providing information on where to find more details, and explaining how to participate.
Confirmed speakers:
- Hugh Glover, Technical Director, Vulcan
- Mary Lynn Mercado, Global Head Protocol Delivery & US Site Head, Regulatory Writing & Submissions, Novartis
- Chris Decker, President and CEO, CDISC
- Noemie Manent, Clinical Trial Transformation (CTT) Change Manager, EMA
- Ron Fitzmartin, Sr. Informatics Advisor, FDA
The webinar welcomes a diverse audience:
- 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)
Register Today!
Don't miss this free informational event for the clinical research community. Get ready for the digital clinical protocol.
