Global and Local Literature Screening
Global and local literature screening intends to identify reportable Individual Case Safety Reports (ICSRs) and detect novel safety signals concerning emerging safety issues. Biomapas offers a comprehensive service spectrum that ensures post-authorization pharmacovigilance (PV) compliance.
We develop sound search strategies and provide you with meaningful results and periodic reports from these searches. We support reviewing and assessing identified literature articles and deliver inspection-ready documentation. Additionally, we formulate comments for articles relevant to:
- Periodic Safety Update Reports (PSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- ICSRs.
We also provide local literature searches in the relevant local journals depending on where you market your product, covering EU, EAEU, and CIS.
All Post-AUthorization Services
Continued Lifecycle Patient Safety.
