Nonclinical Written Summaries demo
The Module 2.4 and 2.6 outline as a binder: agents draft each section and build the tabulated summaries from the study reports, every number tied to its report page. 1:13
What the demo shows
An IND writing solution for regulatory writers that drafts Modules 2.4 and 2.6 from reports.
Lays out the ICH M4S outline as a binder: each heading with the study reports it draws on, coverage and sign-off. Agents read every report, draft each section in the house template with every sentence cited to a page, build the tabulated summaries cell by cell from the same findings, and recompute every number, margin and starting-dose figure. The writer resolves each flag and signs; section owners approve by e-signature.
Transcript
- Nonclinical Written Summaries drafts IND Modules 2.4 and 2.6 from the study reports for regulatory writers.
- By hand, one IND's written summaries take about 100 hours.
- Lena's binder shows each heading with its reports, coverage, and sign-off.
- She opens 2.6.7.7, the pivotal repeat-dose table.
- It builds itself row by row from five reports.
- each value with its report and page.
- The dog exposure, 24,200 from BA 512, page 11.
- The text said 22,400.
- One click takes the source value, and the margin is recomputed.
- Summaries drafted in hours, every number checked before anyone signs.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.