Global and Local Literature Monitoring
Global and local literature monitoring plays a critical role in identifying reportable Individual Case Safety Reports (ICSRs) and detecting emerging safety signals. Biomapas provides comprehensive post-authorisation pharmacovigilance support through scalable global and local literature monitoring solutions tailored to regional regulatory requirements.
We develop robust search strategies and deliver meaningful results, periodic reports, and inspection-ready documentation to support ongoing safety monitoring activities. Our teams support the review and assessment of identified literature articles and provide input relevant for:
- Periodic Safety Update Reports (PSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- ICSRs
Using automated literature monitoring systems alongside experienced multilingual teams, Biomapas supports rapid implementation of local literature monitoring across 120+ countries, including non-indexed and local journals across Europe, EAEU, CIS, MENA, and other international markets.
