Building Comprehensive PV Programs Around A Single Safety Database

What are the keys to building a comprehensive pharmacovigilance (PV) program? Be forward-thinking, invest wisely, and question everything.

As a sponsor of a first-in-human clinical trial, it's easy to overlook how your current decisions will impact the product lifecycle downstream. You might opt for different CROs for clinical and PV needs with each new trial to minimize costs. This could result in varied case reviews by different medics and inconsistent narrative templates. When drafting each Analysis of Similar Events, you may find yourself constantly requesting and merging data from multiple databases just to get a clear view of similarly coded events. Eventually, you may discover that different CRO teams are coding events in slightly different ways, with no overarching convention, leading to doubts about the accuracy of your data and the need for a major harmonization effort.

Instead, imagine if those initial decisions were made with a ten-year plan in mind. Start by selecting a single repository for all safety data and establish uniform coding conventions from the beginning. Being forward-thinking at this early stage can significantly reduce the need for rework and the burden of addressing inconsistencies later.