The Challenge
Post-market surveillance is one of the most demanding responsibilities in regulatory affairs. Teams must continuously monitor multiple FDA databases, track adverse event narratives, and correlate those findings against the published scientific literature—all while managing submission deadlines and internal reporting requirements.
- Manual querying of MAUDE and FAERS separately creates fragmented, incomplete views of emerging safety issues
- Correlating adverse event data with peer-reviewed research requires navigating dozens of disconnected systems
- Delayed identification of safety signals can lead to regulatory action, product liability exposure, and most critically, patient harm
- Pharmacovigilance programs struggle to scale as product portfolios grow
The Autohive Solution
By connecting your agents to the Scite integration, you can automate the entire safety monitoring workflow—from simultaneous multi-database search to cross-referenced literature analysis—all in one place.
Simultaneous Multi-Database Search
Agents query MAUDE (Medical Device Adverse Events) and FAERS (FDA Adverse Event Reporting System) at the same time, retrieving detailed narratives and patient outcomes without requiring separate manual searches.
Automated Literature Cross-Reference
Every adverse event cluster is automatically matched against relevant peer-reviewed studies via Scite’s database of 210+ million papers. Agents identify whether safety signals are supported, contradicted, or under-investigated in published science.
Early Pattern Recognition
By continuously monitoring incoming adverse event reports and comparing them against historical data and clinical trial outcomes, agents can flag emerging patterns before they escalate into formal safety alerts or recalls.
Benefits
- Faster signal detection - Identify adverse event patterns days or weeks ahead of manual review cycles
- Regulatory defensibility - Build audit trails backed by verified database queries and published evidence
- Reduced analyst burden - Free pharmacovigilance teams from repetitive database navigation
- Comprehensive coverage - Monitor FDA, MHRA, and peer-reviewed literature in a single workflow
- Scalable surveillance - Monitor entire product portfolios without proportional headcount increases
How It Works
- Configure your agent - Define the devices, drugs, or compounds your team needs to monitor in the Autohive workspace
- Set search parameters - Specify adverse event types, date ranges, and literature keywords relevant to your products
- Run simultaneous queries - The agent searches MAUDE, FAERS, and Scite’s literature database concurrently
- Receive synthesized reports - Agents compile findings into structured summaries with cross-referenced evidence and citation context
- Trigger alerts - Configure thresholds so your team is notified automatically when signal patterns emerge
Getting Started
- Sign up at app.autohive.com
- Connect the Scite integration from the marketplace
- Configure your surveillance agent with target products and monitoring criteria
- Deploy your agents and receive your first automated safety intelligence report
Learn more about the Scite integration on the Autohive marketplace.
