fda2We founded Advera with the goal of designing a pharmacovigilance platform that provided a modern user interface and next generation data and analytics. The FDA Adverse Event Reporting System (FAERS) was the first dataset we integrated into our Evidex platform.  In those early days, we strived to create an optimal FAERS experience, which meant finding a way to quickly ingest, standardize, and de-duplicate the very messy raw FAERS data.

The scope of our data and analytics offering grew quickly from those early days to include multiple datasets for pharmacovigilance signal detection, validation, and evaluation.  But our commitment to quickly deliver optimized FAERS data remains.

In February 2018, we set a goal to provide our clients with optimized FAERS data 7-10 days from the raw files being publicly released by FDA. That is fast. Many vendors take up to three months to provide the same data.

Since then we released many upgrades to Evidex, including a complete GVP IX based signal management workflow platform, advanced analytics for customized signal detection, and  new ways to link disparate datasets together to more efficiently characterize potential safety concerns.

Through it all, we've remained committed to continuing to refine our FAERS optimization process.

FDA released the Q1 2019 data files late in the day on Wednesday, May 8th. I'm pleased to report that it took us 4.456 days (yes, our engineers calculated the exact time...) to ingest the data files, optimize those data with our algorithms and our humans, and then propagate the updates across the Evidex platform. 

Our clients were the first to see these clean, standardized, and de-duplicated data.

If you are not yet an Evidex client and rely on FAERS data to support your signal detection and management process, you most likely do not yet have access to optimized Q1 2019 data. 

Let us know if you'd like that to change.  

Interested in signal detection best practices? Read Pharmacovigilance Signal Detection: A Complete Guide.

Topics: FAERS, Pharmacovigilance Software

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.