- Bill Illis–VP, Program Lead, Global Development Operations-Novartis
- Richard (Reb) Buckley–Clinical Innovation-TransCelerate/Project Lead-Pfizer
- Stayce Murray–Senior IT Lead Reporting & Analytics-UCB
- Bob Hayden–Principal IS Architect-Amgen
- Michael Morozewicz, Biomedical Data Stewardship, Senior Manager-Amgen
The TransCelerate Digital Data Flow (DDF) Initiative was launched in 2018 with the primary objective of encouraging and facilitating a pathway to digitize the clinical study startup process. This led to development of a Solution Framework and Conceptual Design document, describing the high-level design structure including process, requirements, data, and technical architecture. The conceptual design is centered on the idea of the “clinical study protocol as a data platform.”
The draft Solution Framework and Conceptual Design document will be available on or around mid-October, and all registered participants will receive an email notification when it is available for review.
This free webinar provides the first opportunity to share this document with technology vendors and other interested parties, beginning a process to evaluate feasibility, inform design elements, and to share plans to host a virtual hackathon in early 2020.
- Verify Design viability and receive feedback on Solution Framework and Conceptual Design
- Encourage Engagement with technology vendors, standard setting organizations, health authorities, and other interested parties.
- Share Planned Next Steps Enabling Technology Vendor Engagement on prototyping efforts
The primary audience is technology vendors (e.g. platform developers, service providers, API/integrators, start-ups), as well as biopharma companies, standards setting organizations, and health authorities.