Most conversations about AI in clinical trials are about the technology. The more important question for sponsors is whether AI is delivering measurable operational advantages in real clinical development programs – and whether their CRO has the expertise to apply AI effectively.
This white paper examines the operational, practical reality of agentic AI in phase 2 and 3 clinical trials today, alongside its future potential as adoption and autonomy continue to evolve. It examines how AI is transforming trial operations, decision-making, and execution, and what sponsors should look for when evaluating CRO partners based on strength of expertise in AI.
Included is a sponsor checklist for assessing CRO AI capabilities, alongside PSI’s Expert Operations AI Maturity Model – a framework that maps the evolution of clinical trial operations from reactive, human-led management to fully autonomous, AI-driven execution.
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One of the most important and least discussed questions is not how advanced the AI in clinical trials is, but whether the operational knowledge required to support it exists in the first place. AI rarely fails because the technology is incapable, it fails because critical operational intelligence remains undocumented, fragmented across teams, lost due to loss of talent, or embedded in individual experience rather than structured processes.
Standard operating procedures provide an important foundation, but they only capture part of how clinical trials are delivered.
The organizations best positioned to benefit from AI are those that can translate years of operational expertise into detailed process narratives, decision trees, escalation pathways, exception-handling frameworks, and workflows with a shared operational language.
The challenge isn’t simply automation, it is operational codification.
This white paper extends a panel discussion held at Swiss Biotech Day 2026 into the questions that matter most to clinical development leaders: where agentic AI is creating documented operational value, how workforce roles are shifting as autonomous tooling matures, what process reengineering – not just automation – will look like by 2030, and how sponsors can assess whether their partners possess the operational foundations necessary to realize AI’s potential in their complex phase 2 and 3 trials. Standard operating procedures provide an important foundation, but they only capture part of how clinical trials are delivered
