Event Type 2: Virtual

Building on the success of our previous webinars, we’re excited to announce the next webinar in the series! Join us as we explore Vulcan’s UDP (Utilizing the Digital Protocol)—a project accelerating ICH M11 and end-user value.

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 will:

• 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 

• 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)

TransCelerate webinars may be recorded in whole or in part.  

The DDF Solution Showcase series continues! TransCelerate will cohost the next installment with CDISC, bringing together sponsor companies, clinical solution providers, and key industry stakeholders. Catch up on previous webinars.

During this webinar, our panelists will:

• Share information about innovative products and solutions in the protocol digitalization space
• Present on the following topics and engage in a Q&A session:
  

  • Embracing USDM standards to accelerate eClinical technology setup (CRScube)
  • How USDM powers effective AI use in clinical trials (studyOS)

Panelists:

• CRScube staff members:

  • Sylvain Berthelot, VP Strategy & Marketing 
  • Robert Hay, Marketing & Solutions Consultant 

• studyOS staff members:

  • Ellis Hiroki Butterfield, CEO

Ideal Attendees: ​

• Anyone interested in protocol digitalization and interoperability
• Sponsors and CROs
• Protocol development and authoring communities
• Clinical trial study start-up and system set-up specialists
• Clinical trial digital and technology support
• Data managers, innovation managers, infrastructure managers, and programmers in clinical development
• Clinical data standards leads (e.g., data standards managers and data governance managers)
• Clinical trial technologists (e.g., solution architects, business analysts, and technology managers)
• Technology solution providers involved in clinical trials
• Central laboratories
• Health authorities
• Industry consortia/groups 

All adoption or use of any solution, deliverable, standard, technology, product, or vendor is purely voluntary. No agreement or understanding will be reached through this event or any other DDF event or activities regarding any such adoption.

TransCelerate webinars may be recorded in whole or in part.