Pharmacovigilance Icsr Narrativev0.1.1

A patient in a Phase 3 oncology trial experiences a fatal adverse event. The agent validates the case, computes 7-day and 15-day regulatory clocks for FDA IND and ICH E2A, and produces a draft narrative for safety physician review before expedited reporting.

A spontaneous report from a physician describes a serious unexpected reaction not in the Reference Safety Information. The agent checks serious criteria, confirms day 0, and drafts a narrative aligning with ICH E2D and GVP Module VI for the QPPV's review.

A case published in a scientific journal requires an ICSR narrative. The agent cites the PubMed ID, confirms reporter and patient identifiers, and prepares a non-expedited narrative for a periodic report.

A duplicate case is identified during reconciliation. The agent supports nullification by drafting a narrative for the nullified case and a follow-up narrative for the retained case, with proper case ID cross-referencing.

Offer the skill as an integrated module within pharmacovigilance automation platforms, charging per-case or subscription fees.

Deploy as a backend service for CROs handling ICSR narratives for multiple small sponsors, billing per narrative or per hour.

Integrate into EDC/CTMS to generate narratives directly from case report forms, charging a premium add-on.