Clinical

Saama offers industry-leading AI/ML and advanced analytics-based custom solutions and services that cover the entire clinical trial lifecycle. Our expertise and proven frameworks help us create specialized solutions that accelerate clinical trials, while improving quality and reducing costs.

Post Approval

Post-Approval

Actively monitor real-world data for safety signals.

Post Approval

Active Safety Analytics

Monitor real-world data (RWD) for safety signals.

The Challenge

Typically, sponsors rely on voluntary, spontaneous reports and observational studies to understand a drug’s safety profile after it reaches the market. A top 10 global pharmaceutical company wanted to change this by actively monitoring real-world data (RWD) to detect safety signals.

How Saama Helped

Saama built an advanced analytics engine that could identify new or unexpected safety signals within real-world data (RWD), such as claims data and electronic medical records (EMR). By leveraging the FDA’s sentinel common data model and the TreeScan methodology for detecting safety signals, Saama’s solution was able to scan de-identified RWD from millions of patients to track their experiences with that drug for extended periods of time.

Impact

Automatically identify safety signals for in-market products.

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