Literature Monitoring

Published literature is a required source of safety information, and gaps in monitoring are a common inspection finding — particularly for local-language literature that global databases miss. PharmExpert performs global and local literature monitoring: systematic searches, screening for valid ICSRs and safety information, and documented review to GVP Module VI expectations.

We design the search strategy and select databases deliberately, because an inadequate strategy creates blind spots that surface only at inspection. The strategy is documented and justified so the basis of your surveillance is defensible.

Screening is performed on a defined cadence — typically weekly, consistent with GVP — identifying valid individual cases and capturing aggregate safety information, then feeding both into the safety system for processing and signal detection.

Throughout, we maintain the audit trail that demonstrates complete, timely surveillance, and we cover local and national literature where individual markets require it. The result is literature monitoring that satisfies regulators and genuinely contributes to detecting safety signals.