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Doing our part to improve drug safety

Posted on October 2nd, 2018 by in Pharma R&D


Pharmacovigilance and drug safety teams are never short of work. There’s a vast amount of peer-reviewed literature to sift through for adverse event information. Over 800,000 pharmacology and biomedicine articles are published annually, but only ~5% of those contain information relevant to pharmacovigilance activities.

Then there is the complexity of the workflow itself, with different roles involved in search design, review, risk–benefit analysis, report generation and so on. Some companies outsource part or all their pharmacovigilance activities to CROs, which adds oversight-related tasks to the workflow.

It’s important that pharmaceutical companies have the best solutions for this critical work. After all, safer drugs mean better patient outcomes! That’s why the development teams of Elsevier’s R&D Solutions for Pharmacovigilance

This year, a major focus for the development teams of our R&D Solutions for Pharmacovigilance has been increasing comprehensiveness, efficiency, accuracy and GxP compliance. New features in Embase, PharmaPendium and QUOSA PV have launched or are launching soon, each addressing key challenges.

For example:

  • Embase will soon have a French Local Language Module allowing the incorporation of mandatory screening of French-language content into global processes. It’s the first of many local-language modules designed to increase comprehensiveness, efficiency and compliance of literature monitoring.
  • PharmaPendium’s search module for the FDA Adverse Event Reporting System (FAERS) already lets users build queries around single drugs or specific, self-defined drug groups. It will soon get new heat map and percentage calculation features to accelerate these analyses, allowing new safety signals and insights to be uncovered from FAERS reports.
  • QUOSA PV, our GxP-compliant pharmacovigilance workflow management solution, now has more workflow configurations, including medical review, signal management and quality assurance steps. These additions mean QUOSA PV can easily become an integral part of existing pharmacovigilance workflows and procedures, even in situations where one or more parts of the literature management workflow are outsourced to a CRO.

These are just a few of the changes we’re introducing to our R&D Solutions for Pharmacovigilance. They show our commitment to delivering solutions that help our customers develop safer, more effective drugs.

Find out more about our offering here and join us on October 23 for an exclusive webinar  focused on these enhancements and their impact on pharmacovigilance workflows.

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