While voluntary adverse event reports are vital tools for ensuring safety after drugs go to market, the FDA’s active surveillance approach through the Sentinel System is much more powerful. Saama gives pharma the same real-world data analytics capabilities in order to be more proactive about safety.
- Identify outcomes associated with different drugs
- Understand the safety profiles of competitive products
- Explore potential causal relationships between drug/outcome pairs
- Respond rapidly and comprehensively to regulatory requests and potential findings
Active Safety Analytics for Pharma (ASAP)
Help the sponsors you work with identify new and unexpected safety signals using real-world data (RWD)—healthcare claims and electronic medical records (EMR)—to find associations between their drugs and specific adverse outcomes. ASAP leverages an advanced statistical (TreeSCan) methodology to unlock specific safety signals from billions of records in the health profiles of millions of patients.
- Initiate safety analysis by defining study design parameters
- Review TreeScan alerts and drill down to individual patients
- Assess TreeScan alerts and route for review and approval
- Review reports comparing TreeScan alerts across multiple analyses
Get Started Today
To arrange a demo and learn more about how you can set up ASAP as a secure subscription service in the cloud, contact us!