Pleasanton, California, U.S., September 24, 2026
Veeva Systems Inc. has announced the Veeva Study Builder Agent, a new artificial intelligence solution designed to configure clinical studies from study protocols and accelerate the development of electronic data capture and data-quality environments. Announced on September 24, 2026, the technology is designed to configure Veeva EDC and Veeva Data Quality System (DQS) directly from a clinical study protocol, potentially enabling study configurations to be completed in as little as one day. The agent uses an organization’s existing standards together with the CDISC Unified Study Definitions Model (USDM) to support faster and more consistent clinical study builds. By automating several configuration and testing activities, Veeva says the technology is designed to reduce deviations from established standards while creating audit-ready study builds. The new capability represents another step toward applying AI agents to clinical trial operations and data-management workflows.
Veeva Study Builder Agent Automates Study Configuration
The Veeva Study Builder Agent is designed to take information from a study protocol and use it to configure key components of a clinical data environment. According to Veeva, the agent can configure EDC forms, study visits and edit-check rules, while also creating CQL-based listings within DQS. These functions traditionally require teams to translate protocol requirements into detailed system configurations and then conduct testing before a study can proceed. By automating these activities, the agent is intended to establish a more coordinated workflow between study design and clinical data systems. Veeva says the standards-first approach allows organizations to reuse their existing standards while applying the CDISC USDM, supporting more deterministic and consistent builds across clinical studies.
AI Automation Supports Clinical Trial Data Quality
Beyond configuration, the new agent is designed to automate testing and test-data generation. This capability is intended to help clinical teams validate study configurations before they are used in clinical research. Veeva says that because the agent follows an organization’s established standards and a coordinated process, the resulting study builds can minimize deviations from those standards and be audit-ready by design. Standardization is particularly important in clinical trials because study data must be collected consistently and managed according to predefined requirements. Integrating study configuration, testing and data-quality processes within a standards-based workflow could help organizations reduce manual work involved in preparing clinical systems. The technology therefore combines AI automation, clinical data management and industry standards within a single development workflow.
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Veeva Plans Early Access in December 2026
Veeva Study Builder Agent is planned for early-adopter availability in December 2026. Veeva states that the capability will be part of EDC and will require no additional license. The agent will be delivered as a Claude Cowork plugin and installed through a Veeva-managed GitHub repository. The planned availability provides life sciences organizations with an opportunity to begin evaluating AI-assisted study configuration as part of their existing clinical-data workflows. Veeva’s broader clinical data portfolio includes EDC, DQS and electronic clinical outcome assessment capabilities, reflecting the company’s focus on connecting clinical trial processes through technology and data.
The launch of the Veeva Study Builder Agent highlights the increasing application of AI to operational activities within clinical research. Rather than functioning only as a general-purpose productivity tool, the agent is designed around specific clinical study configuration tasks and established life-sciences standards. Its ability to configure EDC forms, visits, edit checks and DQS listings while automating testing demonstrates how AI can be integrated into specialized clinical trial technology workflows. Veeva says the solution is intended to make study builds faster and more consistent, while its planned December 2026 early-adopter release will provide organizations with access to the new capability. As clinical research becomes increasingly data-intensive, AI-driven automation of study setup and validation could become an important component of digital clinical trial infrastructure.
Source: Veeva Systems press release
