OFF-X Translational Safety Intelligence
A unique translational tool providing drug and class safety intelligence to anticipate risks and drive new competitive value
De-risk your R&D programs
Monitor and anticipate safety signals
Make confident decisions
Integrated data
Benchmark safety profiles and assess risks
Quickly understand safety liabilities of drug classes by comparing the safety profiles of your competitor’s drugs based on daily updated, manually curated data.
Predict preclinical toxicity and anticipate adverse reactions
Connect and integrate critical safety intelligence from early target discovery to post-marketing to anticipate and translate toxicity events from the lab to the clinic.
Support signal prioritization, validation and evaluation
Reduce the time and resources required to retrieve safety intelligence needed to stay abreast of regulatory and pharmacovigilance concerns for a given drug or drug class.
Comprehensive range of safety information sources and dataset
All sourced from peer-reviewed journals, congresses, company communications, clinical trial registries, regulatory agency communications around the world and FDA, EMA, and PDMA approval packages
User-friendly visualizations
Quickly assess critical preclinical toxicity data and clinical safety data with user-friendly visualizations, including:
- Translational safety to anticipate and track potential liabilities as clinical trials start and actions to mitigate risks
- Label reference to compare adverse events on labels by the FDA, EMA, and PMDA
- Structure-toxicity explorer to correlate chemical structures with safety liabilities
- Real-world evidence dashboard to quickly assess new potential safety signals
Time-saving, insightful analytics
Support R&D, clinical and pharmacovigilance teams with comprehensive safety data and analytics, including:
- Comparative table builder to anticipate the safety of novel drugs and combinations or assess the mechanisms behind unexpected toxicities
- Drug score to estimate the strength of evidence supporting a given drug-adverse event association
- Target class score to identify and monitor emerging target class liabilities
- Pathway maps to assess and prioritize investigational target safety based on signaling cascades
Integrate internal data and OFF-X via APIs or data feeds
- Connect to translational safety data ecosystem through APIs or data feeds
- Integrate with in-house data sources and modeling applications
- Enrich and expand depth of internal resources to enable your teams to uncover hidden insights in data
Frequently asked questions
OFF-X is a translational safety intelligence platform that helps pharma and biotech companies anticipate and monitor safety liabilities, benchmark drug and target safety profiles, and detect adverse events for compounds at every stage of drug development and post-approval.
Unlike other safety intelligence providers, OFF-X collects and curates data from a wide range of sources, integrating preclinical toxicity data, clinical adverse event data and pharmacovigilance data in a single platform. Additionally, OFF-X covers drugs across all stages of the lifecycle, including approved, unapproved and discontinued.
OFF-X helps drug developers anticipate the toxicity profile of new targets and drug candidates, and monitor their human translation. OFF-X also supports dynamic target safety assessments by pre-empting the safety of novel targets based on up/downstream targets in their signaling pathways.
With OFF-X, clinical teams gain actionable insights to de-risk studies and maximize the chances of clinical success by benchmarking same-in-class drugs as they advance in development. Our translational safety intelligence helps clinical researchers understand how their drug’s safety profile is influenced by patient characteristics (such as condition, age and gender) and can help them define the right clinical trial endpoints and select the most suitable safety biomarkers.
In the event of unexpected safety findings, OFF-X empowers researchers to act quickly by helping them understand these findings and support effective mitigation strategies.
OFF-X empowers PV teams to easily prioritize safety signals and anticipate potential new signals based on members of the same class, and monitor the role of concomitant medications in unexpected adverse reactions. Pharmacovigilance professionals can anticipate risk factors by benchmarking the safety profiles of investigational, launched and discontinued drugs by target classes. In addition, they can easily compile publications for aggregated reports and prepare comprehensive responses to health authorities’ requests.
Updated daily, OFF-X covers drugs and targets in all phases of R&D & post-marketing, and all drug modalities. A team of experts curates the content from a wide range of sources, including:
- Peer-reviewed literature
- Congresses / conference proceedings
- Clinical Trial registries
- Real World Evidence Databases like FAERS & JADER
- Regulatory documents
- Company communications
- Proprietary disease pathway maps
Food and Drug Administration (FDA) and Clarivate Extend Material Transfer Agreement for Three Additional Years
Partnership enables agency-wide access to OFF-X translational safety intelligence solution London, U.K., May 23, 2023 –– Clarivate Plc (NYSE: CLVT), a global leader in connecting people and organizations to intelligence they…
