Does Burna AI generate regulatory reports such as FDA MedWatch, IRB and SAE reports?

Yes. Burna AI generates three report types from the graded record: the FDA MedWatch 3500A form, the IRB unanticipated problem report, and the sponsor serious adverse event (SAE) report. Each draws the CTCAE term and grade, the per-drug WHO-UMC and Kramer attribution and the source citations from the same record, and downloads as a document for the investigator to review and sign. A serious adverse event also opens a case checklist that tracks the steps a site works through: the sponsor form, records gathered, investigator signature, submission to the sponsor and to the IRB, EDC entry, follow-up and close-out. Periodic and postmarket reports such as DSURs, PBRERs and E2B(R3) case reports are compiled by the sponsor's safety team, and the graded, MedDRA-coded events Burna AI produces are what they are built from. The dated list of what the platform does today is at burna.ai/capabilities.