Medical literature is an important source of information on suspected adverse reaction case reports. As regulations are becoming more stringent, Marketing Authorization Holders (MAHs) may face the challenge of incorporating ever-increasing safety data into their pharmacovigilance (PV) practices to achieve compliance. The quality and efficiency of the literature monitoring process in pharmacovigilance has a significant impact on the quality of ICSRs, periodic safety reports, detection of new safety signals and eventually Benefit-Risk Evaluation (BRE) of medicinal products. Importantly, shortcomings in this critical process have the potential to impact the MAH’s overall Pharmacovigilance activities including Regulatory compliance and also has potential impact on the company’s reputation due to inadequate Benefit-Risk Evaluation (BRE) of the products leading to potential drug recalls.
As a part of the PV literature surveillance process, Freyr assists organizations with specialized literature monitoring services. Freyr’s team ensures the safety is monitored right from the Medical Literature Monitoring (MLM), Global literature and local literature review in identifying ICSRs, signals and information for inclusion in Periodic Safety Update Reports (PSURs).
- Global (Indexed) Literature Monitoring: Weekly monitoring of scientific and medical publications in global databases like PUBMED, Embase, Medline, etc. with specific search strings
- Extensive experience in developing robust search strategies
- Local (Non-indexed) Literature Monitoring: Weekly/monthly monitoring of scientific and medical publications across various local journals in 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) is(are) included in the list of active substances
- Freyr Designed Application – Freyr Impact-L: To streamline the literature management process, which is aimed to create a simple, customizable, and semi-automated literature review and tracking tool to help monitor safety and to meet the associated Regulatory requirements
- Journal Subscription Services
- Translation Services: Real-time translation services with the ensured quality, in partnership with leading translation service providers.
- Procuring Full Texts: One-click access to scientific literature, delivered within hours, right to the user’s inbox