eTMF Quality Check demo

What the demo shows

A Trial Master File solution for clinical operations that files trial documents and lists gaps.

Agents file each trial document to the TMF Reference Model, work out from each site's milestones which documents are due by today, and score every zone at every site for completeness and timeliness; a TMF lead confirms and signs.

Transcript

1. 0:00eTMF Quality Check keeps the trial master file inspection ready for clinical operations.
2. 0:08An outdated delegation log is a classic inspection finding.
3. 0:14TMF zones down the side, sites across, each cell scored against what is due today.
4. 0:22Hatched is not missing.
5. 0:24Nothing is due yet at the new Site 144.
6. 0:29Site 114 shows a red column in Zone 05.
7. 0:33A sub-investigator joined in September, so the agent expects a new delegation log.
8. 0:42It's missing, and the form FDA-1572 was filed 94 days late.
9. 0:52Lena assigns the four gaps to the site's monitor in one step.
10. 0:57Documents now reach the file in under two days, not 38.
11. 1:04Built on Botminds: agents, data, screens, and governance on one platform. Thank you.

Transcribed from the film’s narration. Captions are on the player.