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.
Approach
We created an automated pipeline to handle adverse event reports from six sources. It used an AI-assisted engine to apply MedDRA codes, identified duplicate entries, and prepared MedWatch submission packages automatically. We also set up an escalation process for serious events needing 15-day expedited reporting.
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.
How We Cut MedDRA Coding Time in Half and Slashed Errors with AI
Manual MedDRA coding was killing our speed on adverse event reports. So, we tried out an AI tool that scans the narratives and suggests the right MedDRA preferred terms. Boom, coding time dropped from 45 minutes to just 8 per report. Our pharmacovigilance team didn’t have to start from scratch anymore; they just reviewed the AI’s suggestions. It made a massive difference.
We set up a quick, no-fuss system to catch serious adverse events right away.
The FDA only gives you 15 days to report serious adverse events, crazy tight deadline, right? So, we built this automated triage system to take the heat off. It instantly flags the most urgent cases and fast-tracks them. Then, to keep everyone on their toes, we set reminders for days 7, 10, and 13. It’s simple, but frankly, it changed the game.
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.