Systems of Execution (SoE) in Clinical Development

Clinical trials are becoming increasingly digital yet remain decisively manual. Sponsors and CROs have invested heavily in digital platforms, but without orchestration across these systems, operational blind spots persist. Data is collected, monitored, and reported – but rarely acted upon in real time. Trial execution still relies on manual coordination, disconnected processes, and delayed responses.

What is missing is not visibility, but adaptability. The question is no longer whether we have enough data or tools, but whether clinical systems can sense what is happening, decide what to do next, and act accordingly. Systems that wait for human input are increasingly misaligned with modern clinical development’s speed, scale, and complexity. What is needed is a shift from fragmented enablement to connected intelligence.

This is where Systems of Execution (SoE) come in. By embedding agentic AI across the clinical value chain, SoE enable real-time orchestration of trial activities – detecting risks, triggering actions, and optimizing execution. These systems do not just support clinical operations, they transform them. In this Viewpoint, we share our insights and perspective on the SoE approach to applying agentic AI in clinical trials.