Specialty Pharmaceutical Company · Life Sciences · Philadelphia, PA · 14 weeks
Pharmacovigilance data pipeline automated
A specialty pharmaceutical company handled adverse event reports manually, causing delays that pushed submissions beyond the FDA’s 15-day deadline. We built an automated data pipeline that cut processing time from 18 days to 4 hours and ensured every serious adverse event was submitted on time.
Challenge
The pharmacovigilance team collected adverse event reports from six different channels: call center, field sales, medical affairs, literature monitoring, spontaneous reports, and clinical trials. Each channel used its own data format, forcing the team to manually consolidate and process the information. Despite having eight specialists dedicated to this task, delays persisted, leading to late FDA submissions and warning letters.
Outcome
We cut adverse event processing from 18 days to 4 hours for standard reports and 6 hours for serious cases. This overhaul pushed on-time submission compliance to full within three months. Automating data handling freed up the equivalent of five of the eight specialists’ time, shifting their focus from routine processing to signal detection.
Results
- 18 days to 4 hours Adverse event processing time
- Full On-time FDA submission compliance
- 5 of 8 Pharmacovigilance specialists' time freed
- 6 sources Adverse event data sources unified
We kept missing FDA deadlines and getting warning letters. Our team of eight was overloaded but still couldn’t keep up. Once Thinklytics automated the process, we’ve hit every submission on time. Now, the team focuses on signal detection instead of data entry.