The challenge
A pre-IND tool is not enough for a full IND: the scope, the document set and the checkpoints are different. The product had to be rebuilt around IND scope without losing the traceability that makes the findings usable.
What we built
- Full-IND scope rules, checkpoints and anchors defined by a regulatory lead
- A staged approach: IND gap analysis first, IND drafting second
- A test corpus of generated source documents used to assess accuracy line by line before any accuracy claim is made
- Dashboard and demo flows rebuilt around the IND gap workflow
Outcome
In progress. We do not publish accuracy figures until the evaluation run is complete.
This project is under active development. Details will be updated as milestones are reached.
