Protocol deviations arise during study conduct, at patient visits and site decision points, not at the stage of data entry. By the time deviations are visible in downstream systems, opportunities for timely intervention are often lost.

Late detection increases operational rework, compromises data usability, and elevates regulatory risk.

Existing clinical systems were designed to capture and manage data, not to interpret protocol requirements dynamically or provide early visibility into deviation risk.

As a result, deviation management remains largely reactive rather than preventive.