Global Literature Review

Literature Search

The review of worldwide scientific literature is an essential part of the ongoing safety surveillance of medicinal products, regardless of commercial status. To ensure compliance with regulatory legislation worldwide, it is essential that global and local literature screening, where applicable, is regularly conducted to identify reportable ICSRs and safety relevant information.

Our experienced team at ProPharma can support you or assume full responsibility for these activities to ensure your PV program adheres to the global regulatory requirements.

In addition, our services are cost-effective, and we are able to conduct global literature surveillance of large bibliographical databases including Medline^® via the Biologit platform.

We have extensive experience in developing robust search strategies for our clients and providing results from these searches according to an agreed upon periodicity. We can perform the review and assessment of identified literature articles and ensure the efficient and auditable documentation of results.

We have experience and well-established processes for conducting local literature screenings. We can support you in the set-up and conduct, including the identification of relevant local databases and journals, and translation of articles, if needed.

For Marketing Authorization Holders (MAHs) with active substances included in the EMA’s Medical Literature Monitoring (MLM) list, we perform EudraVigilance checks using the ICSR Export module based on the frequency contracted. In addition, we provide local literature searches in relevant local scientific and medical journals in countries where your product is marketed and where this is legally required.