CTD Module 2 Authoring demo
Lays Module 2 out as a binder, each section with its source studies, citation coverage and sign-off; drafts every section with a citation on each statement, and checks every fact against 2.5, 2.7, 2.3 and Modules 3–5. 1:15
What the demo shows
A regulatory writing solution for submission teams that drafts clinical and quality summaries.
The binder shows the CTD Module 2 tree; every node carries the studies it cites, a citation-coverage ring and its sign-off. Writer agents draft 2.3–2.7 from Modules 3–5 with a citation on every statement; a verifier opens every cited page; a consistency agent checks each fact against the same fact elsewhere in Module 2 and in the source, and lists conflicts on the node with both sources linked and a proposed fix. The section owner applies it and signs.
Transcript
- CTD Module 2 Authoring drafts the clinical and quality summaries for regulatory writing teams. By hand, it takes months, and one mismatched number can stall a review. Each section shows the studies it cites, its coverage, and whose signs. Sam just updated 2.7.4, the safety summary. Maya opens it, and the agent checks each fact against 2.5 in Module 5.
- Exposure turns amber
- 1,935 patients in 2.5.5
- 1,947 here
- 12 apart
- Both sources are linked
- The final report and the old data cut 2.5 still cites
- The agent drafts the fix and sends it to Omar
- who owns 2.5
- Module 2 in weeks, every statement cited
- Built on bot mines
- agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.