Pharmacovigilance and Drug Safety

Efficiently and effectively stay on top of monitoring safety issues raised in biomedical literature about your authorized medicinal products

Speak to us

With the dramatic increase in approved medical products, maintaining vigilance over the corresponding growth in medical literature is taxing regulatory teams.

Reduce burden on your team with an efficient and compliant workflow solution designed to zero in on the most critical, pressing information when you need it.

Enable your pharmacovigilance experts to keep focus on what matters most – patient safety – by using tools and a process that simplifies the repetitive and tedious literature review. Transparently measure the productivity, quality and timeliness of the work performed by your multiple teams. Be confident that your operation is under control, inspection ready, and compliant.

Medical Literature Monitoring for Pharmacovigilance

Content, software, technology, and literature services

Clarivate offers an unrivalled post-marketing end-to-end medical literature monitoring solution for Individual Case Safety Reporting (ICSR), creation of Aggregate Reports, such as PSUR, PBRER, DSUR, and detection of Potential Signals.

The modular solution includes:

  • Access to most relevant drug safety databases for post-marketing surveillance all in one location
  • Easy alerts set up and maintenance and ingestion into the review software
  • Validated drug safety software to organize, assess and report articles containing product safety issues
  • Artificial intelligence engine to suggest reportability and safety relevance for each article
  • Pharmacovigilance experts to perform literature review and search services for you

High-efficiency workflow solution for labor-intensive operation

  • Funnel the world’s medical literature into the essential articles with precision search and deduplication
  • Realize productivity gains and faster reporting with artificial intelligence assistance
  • Integrate alerts ingestion and full text access
  • Conduct review for ICSR, Aggregate Reports and Potential Signals with the automated best practice workflow which reduces the literature noise for the expensive safety physicians by 70%
  • Enjoy performant review operation in a user-friendly interface
  • Manage and oversee with ease the work performed by multiple teams with dashboards, powerful reporting, and quality control capabilities

Compliance and Audit readiness

  • Comply with pharmacovigilance regulations from health agencies such as FDA, EMA and PMDA
  • Access scientific pipeline data that is easily searchable in one platform
  • Effectively manage GxP validation documentation with Quality Management System
  • Ensure your literature surveillance process is audit- and inspection-ready with an audit trail of any action performed by the users, administrators, or system
  • Access a certified solution for Medical Literature Monitoring geared for customer satisfaction

De-risk your R&D programs

  • Benchmark drug safety profiles and assess risks
    Quickly understand drug safety liabilities and new target-action adverse event associations with high-quality data and analytics manually curated by PhD- and MD-level research professionals using OFF-X 
  • Predict toxicity and anticipate adverse events
    Connect and integrate critical safety intelligence from early target discovery to post-marketing and patient safety to anticipate and translate toxicity and safety events derived in the lab to the clinic
  • Support signal detection, prioritization, and evaluation
    Reduce the time and resources required to retrieve safety intelligence needed to monitor regulatory and pharmacovigilance concerns for a given drug class

Our solutions


Get started

Talk to us about your Pharmacovigilance and Safety strategy.

Speak to our team