Medical Literature Monitoring Services - Overview
Medical literature is a source of information for suspected adverse reaction case reports. With stringent regulations, Marketing Authorization Holders (MAHs) might face the challenge of incorporating safety data into their Pharmacovigilance (PV) practices to achieve compliance. The quality and efficiency of medical literature monitoring in the pharmacovigilance process have a significant impact on the accuracy of ICSRs, periodic safety literature reports, detection of new safety signals, and eventually, the Benefit-risk Evaluation (BRE) of medicinal products.
Importantly, shortcomings in the critical process of medical literature monitoring and pharmacovigilance literature monitoring processes have the potential to impact the MAH’s overall pharmacovigilance activities. These activities affect Regulatory compliance and the company’s reputation due to inadequate BRE of the products, leading to possible drug recalls.
As a part of the pharmacovigilance literature monitoring process, Freyr assists organizations with specialized medical literature monitoring in pharmacovigilance. Our team ensures safety is monitored, right from Medical Literature Monitoring (MLM), global literature, and local literature review process in identifying ICSRs, to signals and information for inclusion in Periodic Safety Update Reports (PSURs).
Medical Literature Monitoring Services
- Global literature monitoring (Indexed): Weekly monitoring of scientific and medical publications in global literature databases like PUBMED, Embase, Medline, etc., with specific search strings simplifying the pharmacovigilance literature monitoring process.
- Extensive experience in developing search strategies for PV literature monitoring.
- Local literature monitoring (Non-indexed): Weekly/Monthly monitoring of scientific and medical literature databases and publications across various local journals in the respective countries in different languages.
- Weekly monitoring and reviewing of the Eudravigilance Medical Literature Monitoring (MLM) list, maintained by the European Medicines Agency (EMA) for ICSRs identified in the literature, if the product(s) are included in the list of active substances.
- Freyr designed application: Freyr Impact-L: To streamline the literature management process aimed to create a simple, customizable, and semi-automated literature screening in pharmacovigilance and a tracking tool to help monitor safety and meet the associated Regulatory requirements.
- Journal subscription services for literature review.
- Translation services: Real-time translation services with ensured quality, in partnership with leading translation service providers for flawless literature review.
- Procuring full texts: One-click access to scientific literature, delivered within hours to the user’s inbox.
- Literature monitoring in pharmacovigilance
- Maintaining medical literature databases
- Expertise in the literature review process
