Investigator's Brochure Authoring demo
Last edition's facts beside the proposed ones, every value cited, every place each change touches in the brochure and in the protocols, consent forms and pharmacy manuals that quote it, and the whole IB update drafted as cited tracked changes. 1:20
What the demo shows
A medical writing solution for clinical teams that drafts each annual IB update.
At the annual data cut-off the source collector gathers every report since the last cut-off. Section drafters write each IB section as tracked changes with the source passage for every edit; the fact tracer lists every fact the brochure states, finds every statement of it and compares it with the newest final source; the related-document finder lists the protocols, consent forms and pharmacy manuals that still quote an old value. The IB owner works on one screen, the facts diff, switching rows in or out and tracing facts the tracer adds or keeps out with its check, while the impact counters update and the summary of changes drafts. The medical lead approves; the edition reaches the sites once every country approves it.
Transcript
- Investigator's Brochure Authoring drafts each annual IB update for clinical and medical writing teams.
- By hand it takes five weeks and no one sees every place a changed number appears.
- Veltromap edition 9 to 10, last year's facts on the left, the proposal on the right.
- Exposure rises to 1,846, two places in the brochure, and a consent form still says about 1,200.
- Week 52 remission comes only from a draft interim analysis, so the tracer keeps it out.
- The half-life moves from 26 to 28 days.
- Three statements and two consent forms change.
- The summary of changes drafts itself.
- The contraception period moves from 19 to 20 weeks.
- Dr. Maya Chun approves a cited draft in days, not weeks, with Section 6 updated.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.