The White House OSTP through the Advancing Clinical Trials Readiness Initiative, is building a stronger and more diverse clinical trial infrastructure. This will result in making clinical trials faster, more inclusive, simple and more efficient. Vulcan and CodeX, are working with OTSP on this effort.
The ICH M11 CeSHarP project aims to produce a specification for a digital form of Study Protocols. Vulcan will be helping ICH and its partner organisations CDISC and TransCelerate Biopharma to develop a FHIR Implementation Guide for this and to arrange testing through connectathons.
Vulcan will also be establishing other projects under the heading Utilizing the Digital Protocol to explore additional use cases that a digital protocol can be applied to.
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