Automated Literature Monitoring For Pharmacovigilance

Pharmacovigilance groups depend on targeted, up-to-date product information and adverse event reporting to meet regulatory requirements. Yet, many life science enterprises are compromised by multiple databases that lack integration, and feature insufficient search and alert functions.

Download the QUOSA PV Fact Sheet (PDF, 1.0mb)

QUOSA PV is a pharmacovigilance workflow management tool that centralizes the discovery of critical adverse event information in various types of literature, including information found in the new EMA Medical Literature Monitoring (MLM) initiative.  It promotes efficiency and organizational compliance by automating the monitoring and triage of information in a scalable environment, so you can capture all decisions and provide a detailed audit trail.

Key Benefits

Easy to use, browser-based tool

Review literature and monitor the article pipeline from a single browser-based interface.

Fast identification of adverse events from a broad spectrum of literature sources

Use alerts to monitor AEs reported in literature from multiple literature databases, including both Elsevier and non-Elsevier sources. QUOSA PV automatically de-duplicates content, reducing reviewing time and saving costs.

Rapid assessment with automated literature review and triage

QUOSA PV automates the literature review and triage process, delivering a speedy and efficient, fully trackable process to triage articles, determine relevance for reports and refer to specialists for review.

Improved oversight and efficiency

QUOSA PV optimizes the review process with workload management tools and dashboard views to monitor record trends and incoming alerts.

Lower development and administrative costs with a scalable central library

Store and organize literature in a scalable and secure “cloud-based” environment. Tag and store articles in a central library.

Rapid identification of case and drug-specific data

Store all articles and adverse event/safety data in a searchable product literature safety database, making it easy to find content for case reports and signal detection.

Fully compliant with regulatory best practices

QUOSA PV is qualified to operate in (GxP) regulated environments.

Learn More about Elsevier’s Pharmacovigilance Solutions

Get the whole story on how Elsevier helps pharmaceutical and medical device manufacturers stay compliant with regulatory requirements for adverse event reporting.

Elsevier R&D Solutions for Pharma & Life Sciences - Pharmacovigilance