Adverse Event Intake Agent

Problem

Adverse event reports arrive by email, call centre transcript, portal form, and literature alert, and a valid case starts a fifteen-day regulatory clock from the moment anyone in the company became aware. Intake is manual, the clock is often started late, and a missed reporting deadline is an inspection finding.

Solution

An agent that reads every intake channel, assesses validity against your own procedural definitions, extracts the case into the safety database's fields, and starts the clock at the true awareness date with the evidence for that date recorded.

Tech stack

Required integrations

• Safety database
• Call centre and email intake
• Literature monitoring feeds
• Regulatory submission gateway

Key features

• Validity assessment against the four required elements
• Seriousness and expectedness classification with the reasoning shown
• Awareness-date capture with the evidence retained
• MedDRA coding suggestions for reviewer confirmation
• Reporting clock with escalation well before the deadline