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Veeva Automates Clinical Study Configuration with AI Agent

Clinical trial setup times are set to plummet as Veeva Systems introduces an AI-driven agent capable of configuring study protocols in as little as one day. By leveraging the CDISC Unified Study Definitions Model, the tool automates the creation of EDC forms, edit check rules, and data quality listings.

Bio & NewsSeptember 24, 2026576 reads0

The new Study Builder Agent pulls directly from an organization's existing standards to ensure consistency and speed across clinical research workflows. Beyond basic configuration, the system automates testing and generates the necessary test data to keep builds audit-ready from the start. Chief technology officer Drew Garty described the release as a significant move to simplify and connect fragmented clinical trial processes.

Early adopters will gain access to the agent this December. As a native component of the EDC platform, it requires no additional licensing and functions as a Claude Cowork plugin installed via a managed GitHub repository. Prospective users can preview the technology at the upcoming Veeva R&D and Quality Summit in Boston this October.

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