Elsevier Launches QUOSA PV to Help Pharma Companies Improve Literature Monitoring for Pharmacovigilance

A new version of QUOSA™ will empower rapid, efficient and transparent literature review to save time and improve regulatory compliance

New York, September 14, 2016

Elsevier, a world-leading provider of scientific, technical and medical information products and services, today announced it 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 organizes 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.

Efficiency and compliance
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 continually growing volume of published literature places extra demands on PV systems and teams. PV groups, information managers and drug researchers are constantly challenged to ensure patients’ safety and regulatory compliance with regard to literature monitoring,” said G√ľnther Kurapkat, Head of R&D Solutions for Pharma and Life Sciences, Elsevier R&D Solutions. “QUOSA PV overcomes this challenge and addresses the key issues that are important to our customers by delivering a centralized triage tool that lets users be more confident they are not missing critical safety information.”

Quality by design
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.

Find out more about QUOSA PV.

About Elsevier
As a global leader in information and analytics, Elsevier helps researchers and healthcare professionals advance science and improve health outcomes for the benefit of society. We do this by facilitating insights and critical decision-making for customers across the global research and health ecosystems.

In everything we publish, we uphold the highest standards of quality and integrity. We bring that same rigor to our information analytics solutions for researchers, health professionals, institutions and funders.

Elsevier employs 8,100 people worldwide. We have supported the work of our research and health partners for more than 140 years. Growing from our roots in publishing, we offer knowledge and valuable analytics that help our users make breakthroughs and drive societal progress. Digital solutions such as ScienceDirect, Scopus, SciVal, ClinicalKey and Sherpath support strategic research management, R&D performance, clinical decision support, and health education. Researchers and healthcare professionals rely on our 2,500+ digitized journals, including The Lancet and Cell; our 40,000 eBook titles; and our iconic reference works, such as Gray's Anatomy. With the Elsevier Foundation and our external Inclusion & Diversity Advisory Board, we work in partnership with diverse stakeholders to advance inclusion and diversity in science, research and healthcare in developing countries and around the world.

Elsevier is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers. www.elsevier.com.

Media contact
Christopher Capot
Director, Corporate Relations, Elsevier
+1 917 704 5174