Product Surveillance

We assist our clients to design trending tools with horizontal (internal/historical data) benchmarks.  We have designed an integrated system to capture spontaneously reported adverse events and product complaints, and generate web-based reports available to authorized personnel.  The system defines alert limits and ranks the alert signals based on trending against internal historical norms. The customized module allows for comprehensive filtering (slicing and dicing) based on the investigator’s interest.  The web tool allows for drill-down from the top level ranking dashboard to specific product/event trending over time, down to trending from lot-to-lot, data listing, and specific narratives.  We will work with client’s IT personnel to implement such automated system.