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Introduction to Veeva Study Builder Agent

In a significant advancement for clinical research, Veeva Systems has introduced the Veeva Study Builder Agent. This innovative AI-based tool dramatically streamlines the configuration process for clinical studies, allowing for study setups in as little as one day. Tailored to enhance the efficiency of Veeva’s existing platforms, namely Veeva EDC (Electronic Data Capture) and Veeva DQS (Data Quality System), the Study Builder Agent promises to set new standards in clinical trial management.

How It Works

The Veeva Study Builder Agent operates by taking existing study protocols and automating the configuration of EDC forms, study visits, editing check rules, and generating CQL-based listings within DQS. This automation ensures not only speed but also adherence to established standards, minimizing deviations and preparing studies for audits right from the start. By utilizing an organization's pre-defined standards alongside the CDISC Unified Study Definitions Model (USDM), the agent is designed to create high-quality, consistent, and compliant study constructions.

Benefits of Streamlined Configuration

One of the crucial benefits of the Veeva Study Builder Agent is its ability to optimize study builds, reducing time and resources traditionally spent on these activities. Drew Garty, Veeva’s Chief Technology Officer, emphasizes the tool’s capability to enhance the quality and speed of creating clinical studies. This efficiency is particularly vital as the life sciences sector continues to face pressures for quicker and more effective trial executions.

Moreover, the introduction of this tool signifies a commitment from Veeva to push forward innovation within clinical trials, simplifying processes and connecting various components of clinical research through technology.

Preparation for Early Adopters

Set to be available for early adopters in December 2026, the Veeva Study Builder Agent will not necessitate additional licenses and is offered as a Claude Cowork plugin. It will be accessible from a Veeva-managed GitHub repository, making it easier for users within the clinical data ecosystem to integrate this tool into their existing workflows seamlessly.

To further explore Veeva’s clinical data solutions, including EDC and DQS, industry professionals can attend the upcoming Veeva RD and Quality Summit in Boston on October 20-21, a curated event solely for lifetime sciences industry members.

About Veeva Systems

For those unfamiliar with the company, Veeva Systems is a leader in providing cloud-based applications specifically designed for the life sciences sector. With a strong presence in the industry, Veeva caters to over 1,500 clients, ranging from major pharmaceutical giants to emerging biotech firms. Their focus on product excellence, customer success, and a commitment to balancing stakeholder interests positions Veeva as a pivotal player in clinical data management.

Veeva is not merely about providing software solutions; their ethos as a Public Benefit Corporation reflects a dedication to fostering a positive impact within the industry and the communities they serve. Their innovative approach, as showcased by the Veeva Study Builder Agent, embodies the spirit and direction of future clinical trials.

Conclusion

As Veeva continues to innovate, the Study Builder Agent stands as a promising testament to the potential of AI solutions in redefining traditional clinical trial processes. By simplifying study configuration and enhancing audit readiness, this new tool may very well set the stage for the future of efficient clinical research. For more insights, stay tuned for updates from Veeva Systems and their continued advancements in this ever-evolving field.