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.