Elsevier announced that Sanofi has implemented QUOSA’s literature management tools to automate adverse event monitoring. QUOSA powers the retrieval, storage, tagging and annotation of relevant case reports, allowing for the creation of a centralized repository of product-related scientific literature. This centralized repository supports Sanofi’s Pharmacovigilance team in drug safety and adverse event monitoring, ensuring patient safety and compliance with regulatory reporting requirements in all the markets in which it operates.
“Pharmaceutical companies are continually challenged to ensure regulatory compliance is met. This is no easy task with limited resources, an ever-growing number of literature articles and an increasing portfolio of drugs to be tracked. Left untamed, this presents significant risks in compliance and crucially, in patient safety,” said Michael Rai, general manager of QUOSA at Elsevier. “In response to our many conversations with Information Professionals, we have finely tuned QUOSA to complement current processes to provide a stable, efficient and scalable solution which continues to evolve with future needs. We look forward to working with Sanofi to manage this flow of information and support its Pharmacovigilance teams’ work.”
QUOSA provides software and services to life science companies, enabling them to centralize repositories of scientific literature related to drugs and medical devices, as well as receive alerts about new articles related to their products and other market developments. These not only help Pharmacovigilance and Medical Affairs teams carry out their work effectively and quickly, they also ensure sound information management processes and compliance with regulatory requirements.
QUOSA’s pharmacovigilance solution features three elements that help companies meet their literature tracking objectives. First, Elsevier provides prompt customized professional services through its dedicated Life Sciences Integration Services team. Second, QUOSA can be used as either a desktop application or browser-based technology, facilitating secure and scalable information sharing across multiple regions. Third, QUOSA easily integrates with already existing literature resources like third-party publisher platforms, A&I databases like Embase, and document delivery vendors.
QUOSA is part of Elsevier Life Science Solutions, a suite of interoperable, domain-specific, decision support tools which span the discovery and development workflow; including TargetInsights, Pathway Studio, Reaxys, Reaxys Medicinal Chemistry, PharmaPendium and Embase.