Delivering efficient and compliant PV literature screening

Literature screening as part of a pharmacovigilance workflow is more than just a drug safety regulatory obligation. The outcome — insights into safety issues like drug interactions — allows the creation of required reports and informs decisions that mitigate drug risks, protecting patients and manufacturer reputations.

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Drug Safety Quosa Pharmacovigilance

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4+ sources incl. Embase, Pubmed, etc.
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15 supported roles and user profiles
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36 workflow combinations
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Unlimited documents

How QUOSA PV helps with literature screening

Without a suitable process for PV literature screening, drug safety insights are difficult to find — mainly when working to a regulatory deadline. There is a vast and growing library of medical literature to be searched. Even for a whole team of drug safety experts, this would be incredibly time consuming, with the risk of inefficiencies like the same document being viewed multiple times. Issues with timely processing of records put market authorization holders at risk of regulatory fines.

The ideal solution is an efficient and compliant literature screening solution: QUOSA PV

QUOSA PV Factsheet


See how our workflow management tool promotes efficient and compliant literature screening for pharmacovigilance. QUOSA PV helps you automate literature monitoring of relevant medical databases, streamline assessment of captured information, and easily supervise workflows.

Download QUOSA PV Factsheet (PDF, 270.9 KB)

Pharmacovigilance requires the right literature screening tools

Improved literature monitoring for adverse effects

Key to more efficient rba - QUOSA | Elsevier

To avoid missing information that might require a report or inform risk–benefit assessments, it is essential to maintain a comprehensive, compliant, and efficient system for monitoring literature databases. Here, we look at five key steps in improving the efficiency of literature screening workflows.

Learn more about RBA (PDF, 572.9 KB)

Balancing in-house and outsourced monitoring


Balanced handling of pharmacovigilance challenges - R&D Solutions | Elsevier

Combining outsourced literature management with an in-house solution can help companies overcome search challenges by improving oversight, increasing efficiency and providing greater flexibility in managing workload.

Read the white paper

QUOSA PV promotes efficiency and compliance by letting you:

  • Review medical literature and monitor the article pipeline from a single browser-based interface
  • Reduce review time by automatically de-duplicating search results
  • Quickly identify adverse drug safety events from a broad spectrum of sources
  • Rapidly assess information with automated literature screening and triage
  • Improve oversight and efficiency with workload management tools and dashboard views
  • Optimize the interface for your processes with flexible workflows and user roles
  • Rapidly identify case, signal and drug-specific data with a searchable database
  • Ensure compliance with regulatory best practices and GxP-regulated environments

Pharmacovigilance groups depend on targeted, up-to-date product information and adverse event reporting to meet regulatory requirements. However, workflows become overcomplicated due to increasing amounts of data, multiple information sources lacking integration and standardized search and alert functions. What’s more, with global teams, oversight can be challenging.

How QUOSA PV helps
Centralize discovery and review of critical adverse event information from various sources, including peer-reviewed literature databases and information from the EMA Medical Literature Monitoring (MLM) initiative. QUOSA PV is a GxP-compliant pharmacovigilance workflow management tool that streamlines database monitoring, supports document triage and review, and facilitates oversight and auditing.

QUOSA PV promotes efficiency and compliance by letting you:

  • Review literature and monitor the article pipeline from a single browser-based interface
  • Reduce review time by automatically de-duplicating search results
  • Quickly identify adverse events from a broad spectrum of sources
  • Rapidly assess information with automated literature review and triage

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  • Improve oversight and efficiency with workload management tools and dashboard views
  • Optimize the interface for your processes with flexible workflows and user roles
  • Rapidly identify case, signal and drug-specific data with a searchable database o
  • Ensure compliance with regulatory best practices and GxP-regulated environments

How QUOSA PV works

See how our workflow management tool promotes efficient and compliant pharmacovigilance. QUOSA PV helps you automate monitoring of relevant databases, streamline assessment of captured information, and more easily supervise the workflow.

Download the Fact Sheet (PDF, 271kb)

Featured customer story

Donna Sees, Information Consultant with PharmIntell Consulting, discusses post-market surveillance best practices for medical device companies and how QUOSA helps.

Read the customer story (PDF, 521kb)


Ideas and insights for industry professionals

Pharmacovigilance requires the right tools

Literature monitoring can help you report adverse events fast only if your process is up-to-date. With more data today than ever before — and more adverse events reported —monitoring has become more challenging. But the right solutions can help you.

Watch the video

Balancing in-house and outsourced monitoring

A balanced approach to literature monitoring - R&D Solutions | Elsevier

Combining outsourced literature management with an in-house solution can help companies overcome search challenges by improving oversight, increasing efficiency and providing greater flexibility in managing workload.

Read the white paper


Learn more about Elsevier's R&D Solutions for Pharmacovigilance

Thousands of pharmacovigilance and drug safety teams at pharmaceutical companies rely on Elsevier's R&D solutions and services. We have focused on providing comprehensive coverage of drug safety data sources and alleviating challenges with pharmacovigilance processes. In addition to QUOSA PV, drug safety teams worldwide benefit from the support of these solutions and services.

PharmaPendium

Make more informed decision on drug safety and efficacy, risk and study design. PharmaPendium delivers comparative drug interaction data and facilitates searches of FDA and EMA drug approval document sources, including FAERS.

Discover PharmaPendium

Embase

Improve monitoring of biomedical literature for adverse events. Embase is the world's most comprehensive database of peer-reviewed and grey biomedical literature. It includes crucial non-English content and offers unique support for search design.

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Professional Services

Let informatic and analytics experts support your drug safety goals. Our Professional Services team can streamline adverse event and safety signal detection by validating search strategies and implementing solutions for literature triage and review.

Discover Professional Services