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Global and Local Literature Screening

Partnering with You to Ensure Compliance

To ensure compliance with regulatory legislation worldwide it is essential that global and local literature screening identify reportable Individual Case Safety Reports (ICSRs) and detect new safety signals for emerging safety issues.

Our experienced team at ProPharma Group can support you with all of these activities to ensure your pharmacovigilance (PV) program adheres to the global regulatory requirements.

Wide Range of Postmarketing Services

ProPharma Group’s comprehensive suite of services ensure you meet all PV obligations.

Our services are cost-effective and we are able to conduct global literature surveillance of the large bibliographical databases of Embase® and Medline®.

We have extensive experience in developing robust search strategies for our clients and provide results from these searches according to an agreed periodicity.

We help with the review and assessment of identified literature articles, ensure the efficient and auditable documentation of results, and write company comments for articles relevant for Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and ICSRs.

For Marketing Authorization Holders (MAHs) with active substances included in the European Medicines Agency (EMA)’s Medical Literature Monitoring (MLM) list, we perform weekly EudraVigilance checks using the ICSR Export module.

Additionally, we provide local literature searches in relevant local journals of every EU country where your product is marketed.

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Need Help Managing Your Drug Safety Requirements?

Contact us to learn how our clinical and postmarketing PV services can support your needs on a standalone basis or integrated with global Medical Information and Regulatory services.

Interested in gaining an industry edge? Let us help you stay current.


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