Medical Literature Monitoring Services

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, Pharma Wizard 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).