The tool pulls from an organization’s existing standards and utilizes the CDISC Unified Study Definitions Model to ensure consistency across trials. By automating the creation of EDC forms, visit schedules, and edit check rules, the agent handles the heavy lifting of backend configuration. It also generates test data automatically, producing results that are audit-ready by design.
Drew Garty, chief technology officer of Veeva Clinical Data, described the release as a move toward simplifying and standardizing the clinical trial landscape. The agent functions as a Claude Cowork plugin and will be available to early adopters starting in December 2026. Because the technology is integrated directly into the existing EDC platform, it requires no additional licensing fees. Interested parties can preview the solution at the upcoming Veeva R&D and Quality Summit in Boston.




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