Protocol Deviation Management demo
Every protocol deviation classified against one spec, whichever team logged it, with causes and site signals on one map. 1:12
What the demo shows
A clinical quality solution for study teams that classifies each deviation and shows trends.
Reads each deviation from CTMS, EDC, IRT and visit reports, assigns cause and importance against the study's classification spec, cites the protocol section and the closest signed decisions, and sends disagreements to the medical monitor. A cause map shows where deviations come from and lights up site signals; the CSR listing and DV tabulation are built from confirmed decisions.
Transcript
- Protocol Deviation Management classifies every trial deviation one way, for sponsors and their CROs.
- Each CRO labels deviations its own way.
- VLT-302 has 418, the important ones in amber.
- Maya clicks visit out of window, 118 open, filtered.
- Site 114 lights up, 19, 10 since its trained assessor went on leave.
- One spec for every team.
- The classifier agrees with Maya 96%.
- Ashgrove said not important.
- The classifier says important, citing the spec row.
- Maya signs, and her reason becomes the next precedent.
- Every deviation classified in minutes, the same way at every site.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.