Watch this webinar to learn about Vulcan’s Utilizing the Digital Protocol (UDP), an umbrella project that brings together multiple initiatives to develop a digital representation of a study protocol.
Slides can be viewed here. Watch the webinar here.
During the webinar, our panelists:
- Outlined the goals of the UDP project, addressing the who, what, when, where, and why aspects.
- Delivered a summary of the first UDP Connectathon in May, highlighting the feedback, key learnings, and planned follow-up actions.
- Described the intent and potential impact of M11 from the ICH M11 perspective.
- Announced the upcoming UDP Connectathon in September, detailing its goals and objectives, providing information on where to find more details, and explaining how to participate.
- Facilitated a Q&A at the end of the webinar.
Panelists:
- 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
- Ron Fitzmartin, Senior Advisor, Office of Regulatory Operations, CBER FDA
- Noemie Manent, Clinical Trial Transformation (CTT) Change Manager, EMA
Ideal Attendees for Webinar Recording:
- 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)