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
