,Medical Literature Monitoring Services - Overview
Medical literature is a critical source of information for suspected adverse reaction case reports. With stringent regulations, Marketing Authorization Holders (MAHs) must integrate this safety data into their Pharmacovigilance (PV) practices. The quality of Medical literature monitoring significantly impacts ICSRs, periodic Literature Reports, and the detection of new safety signals, which are all essential for the Benefit-Risk Evaluation (BRE) of medicinal products.
Shortcomings in the Literature Review Process can impact a MAH’s overall pharmacovigilance activities, affecting regulatory compliance and company reputation. As part of our comprehensive Medical Literature Monitoring Services, Freyr assists organizations with specialized solutions. Our team ensures safety is consistently monitored, from identifying ICSRs and signals through Literature Screening to providing information for Periodic Safety Update Reports (PSURs).
Medical Literature Monitoring Services
- We perform weekly monitoring of scientific and medical publications in global databases like PUBMED, Embase, and Medline, using specific search strings to simplify the Literature Monitoring process.
- Extensive experience in developing effective search strategies for Literature Monitoring in Pharmacovigilance.
- Our team conducts weekly/monthly monitoring (as agreed with customer or as per local regulations) of scientific and medical literature across various local journals in respective countries and languages.
- We provide 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.
- Our proprietary application streamlines the management process with a semi-automated tool for Literature Screening in Pharmacovigilance, helping to monitor safety and meet regulatory requirements. Our Medical Literature Monitoring Services leverage this technology for maximum efficiency.
- Journal subscription services to support the literature review.
- Real-time, high-quality translation services in partnership with leading providers.
- End-to-end management of pharmacovigilance literature monitoring.
- Maintenance and management of medical literature databases.
- Expertise in the entire literature review process from start to finish.
