Compliant Literature Monitoring Under ICH E2C(R2) and GVP Module VI

Periodic literature monitoring is a regulatory obligation, not a research task. ICH E2C(R2) and GVP Module VI expect a process that is consistent, documented and reproducible, a bar a one-off, ad-hoc database search simply cannot clear.

Validated, reproducible search strings

The search strategy must be documented and validated so that an inspector can re-run it and get the same result. That means structured MeSH headings and comprehensive drug spelling variants in TIAB fields, per drug-AE combination, not a freehand query that varies by analyst.

Evidence tables and triage

Every retrieved article needs to be de-duplicated, classified by study type and adverse event, and scored, so the team can show, and defend, why each was included, excluded or escalated.

Audit trails by default

Defensibility comes from traceability. Decisions captured automatically, with timestamps and rationale, turn the review from a vulnerability into evidence of control.

Pharos Scout

Pharos Scout is purpose-built for this: a validated MeSH + TIAB query builder, consolidated AE-wise evidence tables and a scientific narrative prioritisation framework, audit-ready literature surveillance that maps directly to ICH E2C(R2) and GVP Module VI.