At X Pharma Plus, we make pharmacovigilance simpler and more effective with our expert medical literature monitoring services. Leveraging global and local literature management, advanced search strategies, and ensuring high-volume pharmacovigilance activities are executed with accuracy, compliance, and efficiency.
Literature Monitoring Services – Overview
Medical literature is a vital source of information for suspected adverse reaction reports. Marketing Authorization Holders (MAHs) must integrate this data into their pharmacovigilance (PV) systems to comply with stringent regulatory requirements.
Effective medical literature monitoring directly impacts:
- The accuracy of Individual Case Safety Reports (ICSRs)
- Timely preparation of Periodic Safety Update Reports (PSURs)
- Early detection of new safety signals
- Comprehensive Benefit-Risk Evaluations (BRE) of medicinal products
Failure to maintain robust literature monitoring can affect overall PV operations, regulatory compliance, and organizational reputation.
X Pharma Plus provides end-to-end Medical Literature Monitoring (MLM) solutions, from global and local literature reviews to identification of ICSRs and safety signals for inclusion in PSURs, ensuring that safety and compliance are always maintained.
Literature Monitoring Services
“Continuous review of scientific publications and grey literature to identify, assess, and report emerging safety signals.”