Translate complex safety data into clear pharmacovigilance decisions
Anticipate new safety signals, act faster on emerging risks, and defend every decision with translational safety intelligence.
- Identify and contextualize safety risk across the product lifecycle — from investigational to marketed and discontinued products, with intelligence organized by drug, target and class.
- Bring fragmented safety evidence together from labels, literature, safety databases and real-world evidence, supported by trusted curated safety intelligence.
- Respond faster with defensible, source-backed evidence from a safety intelligence resource used by leading pharma and regulatory agencies, including the U.S. FDA.
Request more information
Translational safety intelligence for PV teams
OFF-X is a translational safety intelligence solution that empowers pharmacovigilance teams to anticipate adverse reactions, validate signals faster, and de risk patient safety decisions across the full product lifecycle.
Prioritize and assess safety signals with clarity
Cut through signal noise with class based safety intelligence that helps you prioritize, validate, and contextualize emerging safety signals in-line with evolving evidence.
Uncover mechanisms behind unexpected findings
Go beyond counts and disproportionality. Link adverse events to drugs, targets and classes to understand potential mechanisms and support robust mitigation strategies.
Assess RWE signals in full context
Interrogate FAERS and JADER signals alongside curated safety intelligence so you can distinguish noise from risk, refine hypotheses, and strengthen your benefit–risk rationale.
Understand the impact of concomitant medicines
Quickly explore how co-administered drugs and labeled adverse reactions may contribute to SUSARs, helping you refine case evaluation and risk minimization strategies.
Accelerate reports and health authority responses
Spend less time hunting for references and more time on interpretation. Compile evidence for aggregated reports and health authority queries from a single, curated safety source.
Get instant, conversational access to insights
Use the OFF-X Safety Assistant to ask focused questions about drugs, targets or events and surface relevant safety evidence and sources in seconds, grounded in trusted OFF-X content.