Active Safety Analytics for Pharma (ASAP)

Saama’s Active Safety Analytics for Pharma (ASAP) is an advanced analytics engine that can identify new and unexpected safety signals based on real-world data (RWD), such as healthcare claims and electronic medical records (EMR).

ASAP is the first viable, validated active safety analytics solution for the Life Sciences industry. This powerful data science solution mirrors the capabilities developed by the FDA through the Sentinel Initiative and empowers drug developers to:

• Actively identify safety concerns during routine safety surveillance
• Understand the safety profiles of competitive products
• Identify all drugs associated with a specific outcome
• Explore potential causal relationships between drug/outcome pairs
• Respond rapidly and comprehensively to regulatory requests and potential findings

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.

Active Safety Surveillance Greatly Enhances Your Safety Surveillance Efforts

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.

With the active surveillance offered by ASAP, using real-world data from hundreds of millions of patients, sponsors can proactively track individual experiences with a drug for an extended period of time. As data from vendors like IQVIA and Optum is already scrubbed of all identifying markers, patient data privacy is maintained while safety surveillance is greatly improved.