The surge in clinical trial data volume has pushed pharmaceutical companies to seek automated alternatives to traditional, labor-intensive workflows. By utilizing AI-driven classification and direct integration with systems like Veeva CTMS, the platform allows for real-time monitoring of protocol deviations and key risk indicators. This transition toward risk-based quality management aligns with updated regulatory guidelines, such as ICH E6(R3).

Ibrahim Kamstrup-Akkaoui, vice president at Novo, noted that the system assists in managing, formatting, and preparing complex datasets for submission with greater efficiency. Pavel Burmenko, who leads Veeva DQS strategy, added that the technology is shifting the focus of data managers from manual oversight to strategic partnership roles. As the company continues to expand its ecosystem, recent additions like the Study Builder Agent aim to further accelerate trial setup by configuring EDC and DQS directly from study protocols.