Helping companies around the world navigate the regulatory maze

Global & Local Literature Services

Mapi has a dedicated and qualified Medical Research Librarian specializing in accessing medical and scientific literature. Mapi has access to Medline and Embase via an OVID interface, and conducts searches of the literature on a daily basis to identify Individual Case Safety Reports (ICSRs), articles for aggregate safety reports, for risk management plans, signal detection/management, or for ad-hoc safety reports.

We offer a flexible range of literature citation services, including just providing the search outputs to the client for review, providing the output and performing a preliminary review, being responsible for all aspects of review, ordering full articles and reviewing those, and/or complete processing of ICSRs identified in the literature.

In addition, Mapi can perform searches of local journals available on-line, but not indexed by PubMed or Embase.

A typical literature search process includes:

  • Use of a standardized validated set of search criteria designed to meet the requirements of EEA Good Pharmacovigilance Practices, Health Canada requirements, and US FDA requirements for identification of ICSRs;
  • Searches of Medline and Embase scheduled to run at a frequency agreed with the Client, e.g. weekly;
  • Customized literature searches to meet specific needs;
  • Expert screening to identify specific citations capturing potential ICSRs or articles for aggregate safety reports and risk management plans;
  • Full review and complete processing of ICSRs identified in the literature;
  • Concise and timely communications to clients regarding search findings;
  • Retrieval of full text articles;
  • English translation services.

Request a consultation with an Strategic Regulatory Services expert