Adverse Event Case Narrative Writer for ICSR and CIOMS Reporting

For pharmacovigilance associates, drug safety physicians and CRO safety teams: a structured, chronological adverse event case narrative for ICSR/CIOMS I reporting, with seriousness, expectedness, causality assessment and follow-up queries.

Use cases

• A PV associate turning a messy HCP call note and discharge summary into a CIOMS I-ready narrative within the 15-day clock.
• A CRO safety team drafting a SUSAR narrative from CRF extracts with Hy's law assessment for medical review.
• A small MAH's QPPV office generating prioritised follow-up queries for an incomplete consumer report.