Literature monitoring is a regulatory obligation, not a research task. ICH E2C(R2) and GVP Module VI set expectations that a one-off database search cannot meet.
Validated, reproducible search strings
The search strategy must be documented, validated and reproducible. An inspector should be able to re-run it and get the same result. Ad-hoc searching fails this test.
Evidence tables and audit trails
Every decision, included, excluded, escalated, has to be traceable. Evidence tables and audit trails are what make the process defensible.
Tool-governed delivery
Our Literature Monitoring Tool is purpose-built for ICH E2C(R2) and GVP Module VI: validated search strings, structured evidence tables and complete audit trails by default.
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