Improve pharmacovigilance using FDA-recommended active safety surveillance
Pharmacovigilance professionals can now use real-world evidence from electronic medical records and insurance claims to search for safety signals. This type of active surveillance puts the power of the FDA’s Sentinel Initiative into pharma’s own hands.
Developed through a collaboration with Gilead Sciences, ASAP leverages the FDA’s Sentinel Common Data Model and TreeScan methodology for detecting safety signals. The TreeScan models were adopted to various study designs with scientific advice from Dr. Robertino Mera, Executive Director, Epidemiology, Gilead Sciences, and Dr. Judith Maro, Operations Lead of FDA Sentinel Operations Center, through a collaboration with the Reagan-Udall Foundation for the FDA.
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Governance • Curation • Harmonization Orchestration • Unified Data Model • Metrics Ad-Hoc Reporting • Conversational UX
Active Safety Surveillance
Until now, sponsors have only been able to rely on voluntary, spontaneous reports and observational studies to understand a drug’s safety profile after it reaches the market. Reporting is limited by personal judgment, and any reports that do come in remain isolated data points in a patient’s life that can’t be used for follow-up or continued surveillance.
ASAP is an advanced analytics engine that can identify new and unexpected safety signals based on real-world data from hundreds of millions of patients. The solution enables pharmaceutical companies to track individual experiences with drugs over an extended period of time and explore potential causal relationships between drug/outcome pairs.
Competitive Product Monitoring
ASAP allows companies to explore the safety profiles of any drug that’s currently in the marketplace.
Proactive safety monitoring makes it easier to respond rapidly and comprehensively to any regulatory requests related to potential safety concerns.
Helping Our Customers Succeed with Active Safety Analytics
Gilead’s commitment to advances in pharmacoepidemiology is reflected in our partnership with Saama to create ASAP to push the boundaries of safety for new and existing medicines,” said Dr. Mera. “ASAP can effectively complement existing spontaneous safety surveillance capabilities to provide Biotech and CROs with a comprehensive safety surveillance framework that will help enable the next generation of life-changing medicines.
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!