Support for Drug Safety Monitoring
and Reporting Regulations
Pharmaceutical companies require highly efficient pharmacovigilance workflows to fulfill the mandatory product reporting regulations. The ideal solution should enable screening of the scientific literature for adverse events, triage for relevant scientific articles and storage of information for PSURs, ICSRs and other compliance reports.
Download the QUOSA Fact Sheet for Drug Safety (PDF, 285kb)
Automate the Screening of Scientific Literature
for Adverse Events
Tracking and reporting adverse events is not merely an scientific information management nicety – it is a necessity for regulatory compliance, medical affairs support and strategic product development.
Pharmacovigilance groups depend on targeted, up-to-date product information and adverse event reporting to meet regulatory requirements. But many life science enterprises find themselves compromised by multiple databases that lack integration and feature insufficient search and alert functions that could miss important scientific articles, resulting in information gaps and potential non-compliance.
Given the stakes, life science organizations cannot afford anything less than a scientific literature screening workflow that is that is comprehensive, timely and easy to manage.
QUOSA helps you automate the process of monitoring and triaging scientific articles in a scalable environment
- Broad scientific literature coverage
- Automated alerts
- Full text access
- Expert support
Rapid identification of adverse events
Rapid identification of adverse events Use alerts to monitor AEs reported in scientific literature.
Monitor a broad spectrum of scientific literature sources
QUOSA supports many third-party scientific literature databases, including Elsevier and non-Elsevier content.
Automate the scientific literature review and triage process
QUOSA allows scientific article tagging and storage in a central life science library to facilitate a speedy and efficient process to triage scientific articles and determine relevance for reports.
Implement sophisticated search strategies
Elsevier's experienced professional services team will work with you to make sure your searches capture appropriate scientific literature for regulatory compliance.
Reduce development and administrative costs with a scalable central life science library
Store and organize scientific literature in a scalable and secure “cloud-based” environment. Managing high volumes of content, QUOSA automates the process of de-duplicating and organizing full-text scientific literature.
Learn More About Pharmacovigilance with Elsevier
Get the whole story on how Elsevier helps pharmaceutical and medical device manufacturers stay compliant with regulatory requirements for adverse event reporting.