Delivering efficient and compliant PV literature screening
Literature screening as part of a pharmacovigilance workflow is more than just a drug safety regulatory obligation. The outcome — insights into safety issues like drug interactions — allows the creation of required reports and informs decisions that mitigate drug risks, protecting patients and manufacturer reputations.
How QUOSA helps with literature screening
Without a suitable process for PV literature screening, drug safety insights are difficult to find — mainly when working to a regulatory deadline. There is a vast and growing library of medical literature to be searched. Even for a whole team of drug safety experts, this would be incredibly time consuming, with the risk of inefficiencies like the same document being viewed multiple times. Issues with timely processing of records put market authorization holders at risk of regulatory fines.
The ideal solution is an efficient and compliant literature screening solution: QUOSA
See how our workflow management tool promotes efficient and compliant literature screening for pharmacovigilance. QUOSA helps you automate literature monitoring of relevant medical databases, streamline assessment of captured information, and easily supervise workflows.
Pharmacovigilance requires the right literature screening tools
Improved literature monitoring for adverse effects
To avoid missing information that might require a report or inform risk–benefit assessments, it is essential to maintain a comprehensive, compliant, and efficient system for monitoring literature databases. Here, we look at five key steps in improving the efficiency of literature screening workflows.
Balancing in-house and outsourced monitoring
Combining outsourced literature management with an in-house solution can help companies overcome search challenges by improving oversight, increasing efficiency and providing greater flexibility in managing workload.
QUOSA promotes efficiency and compliance by letting you:
- Review medical literature and monitor the article pipeline from a single browser-based interface
- Reduce review time by automatically de-duplicating search results
- Quickly identify adverse drug safety events from a broad spectrum of sources
- Rapidly identify case, signal and drug-specific data with a searchable database
Learn more about Elsevier's R&D Solutions for Pharmacovigilance
Thousands of pharmacovigilance and drug safety teams at pharmaceutical companies rely on Elsevier's R&D solutions and services. We have focused on providing comprehensive coverage of drug safety data sources and alleviating challenges with pharmacovigilance processes. In addition to QUOSA, drug safety teams worldwide benefit from the support of these solutions and services.
Make more informed decision on drug safety and efficacy, risk and study design. PharmaPendium delivers comparative drug interaction data and facilitates searches of FDA and EMA drug approval document sources, including FAERS.
Improve monitoring of biomedical literature for adverse events. Embase is the world's most comprehensive database of peer-reviewed and grey biomedical literature. It includes crucial non-English content and offers unique support for search design.
Let informatic and analytics experts support your drug safety goals. Our Professional Services team can streamline adverse event and safety signal detection by validating search strategies and implementing solutions for literature triage and review.