The Deviations Your Monitors Never See and Performance Gaps You Didn't Know About

About this session

Sponsored by Espresso Clinical. Findings from a retrospective analysis of a completed Phase 3 study - detection time for protocol deviations, deviations and safety events the oversight system missed, and stakeholder performance gaps that were visible in the data throughout. Why deviations reach the sponsor long after the data already showed them - and why some never arrive at all: visible in structured data within days from event, in the sponsor's log months after that. How reconciling EDC, IRT, eCOA and safety data against the CRO's own monitoring reports surfaces safety blind spots and site-level signals while the visit window is still open - rather than at database lock. Where AI belongs and where deterministic rules belong - and why glass box decides your validation and inspection story: every flag, however it was found, opens onto the exact source records behind it, so a reviewer judges the evidence rather than taking the system's word for it.

Speaker

• JJ

  Jagoda Jablonska

  Head Data · Espresso Clinical

  Speaker