Pharmacovigilance and Drug Safety
Efficiently and effectively stay on top of monitoring safety issues raised in biomedical literature about your authorized medicinal products
With the dramatic increase in approved medical products, maintaining pharmacovigilance over the corresponding growth in medical literature is taxing regulatory teams.
Efficient and compliant workflow solution
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.
Focus on patient safety
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.
Measure productivity and quality
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.
Our solutions
Medical Literature Monitoring for Pharmacovigilance
Content, software, technology, and literature services
Centralized aggregated access to medical literature for drug safety alerts setup and ingestion for review, validated software for safety reporting, and expert literature review and search services.
Optimized literature management with precision search and AI
Funnel the world’s medical literature into essential articles with precision search and deduplication. Realize productivity gains and faster reporting with AI assistance.
Streamlined literature ingestion and workflow optimization for safety teams
Integrate alert ingestion and full-text access. Automated best-practice workflow reduces literature noise by 70% for safety physicians. Oversee work of multiple teams with dashboards and reporting.
Compliance and audit readiness
Comply with FDA, EMA, and PMDA pharmacovigilance regulations with audit trail, timeliness and quality reporting, and GxP validation documentation.
Benchmark drug safety profiles and assess risks
Quickly grasp drug safety liabilities and target-action adverse events with high-quality, manually curated data from PhD- and MD-level experts using OFF-X.
Predict toxicity and anticipate adverse events
Integrate safety intelligence from discovery to post-marketing, translating lab toxicity events to clinical insights for patient safety.
