STM publisher Elsevier has updated its pharmacovigilance (PV) portfolio with the launch of QUOSA PV. This new version of Elsevier's QUOSA literature management solution is specifically designed for the monitoring and review of scientific literature for adverse drug events.
QUOSA PV, developed by PV experts for PV experts, is a tool that organises and automates the monitoring and triaging of articles, and other forms of literature, in a scalable environment. It will help PV groups address patient safety, ensure transparency, maintain compliance with regulatory guidelines and improve the efficiency of the literature screening workflow. QUOSA PV, which also supports the EMA's Medical Literature Monitoring (MLM) program, delivers a user-friendly, browser-based interface, empowering rapid, transparent literature surveillance and case triage. In addition, it is qualified to operate in a Good Practice (GxP) regulated environment.
In order to meet regulatory requirements for monitoring various sources of literature for adverse drug events, PV groups may depend on purchased or internally developed systems. However, these applications are typically neither scalable nor specifically designed for PV, lacking sufficient search, triage and alert functions. Legislation from 2012 means the number of literature articles that must be processed is continually rising, resulting in identification of more adverse events (AE) than historically has been the case. As a result, more resources are needed to ensure all AEs are captured and evaluated rapidly, increasing the need for more efficient and structured workflow management for an increasing number of articles and alerts. Further, some existing tools used for literature review and triage also struggle to meet the stringent compliance demands in place for reporting AEs, such as the need to track review histories and demonstrate transparency in case of audits.
Integrate EMA Medical Literature Monitoring (MLM) service results into the review process
The European Medical Agency's (EMA) MLM program – which came into effect in September 2015 – requires PV groups to review daily reports from the EMA. These reports can be uploaded and cross-checked in QUOSA PV, reducing the need to use multiple tools, saving time and ensuring accuracy.
The QUOSA PV tool is qualified to operate in a GxP regulated environment; it also offers a searchable and exportable audit trail to help with inspection readiness. By automating the process of deduplicating and organizing literature, the screening process is more cost effective and efficient. In addition, by reducing the burden of time spent sifting through large amounts of content and instilling confidence that all relevant information is identified and analyzed, PV groups can focus on their primary role of ensuring patient safety.
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