AE Connect's AI triage engine reads every adverse event narrative the moment it's submitted, auto-coding MedDRA terms, assessing causality, classifying seriousness, flagging expedited cases, and generating ICSR-ready narratives. Your PV specialist reviews the AI's work. Not the other way around.
Each adverse event submission passes through six AI analysis layers before it reaches your PV team. Every assessment includes confidence scores and full audit trail, nothing is a black box.
The AI reads the reporter's free-text narrative and maps adverse events to MedDRA terminology, from System Organ Class down to Lowest Level Term. Multiple events per case are identified and coded independently.
The AI evaluates the relationship between the suspect drug and each adverse event using established pharmacovigilance methodology, temporal association, dechallenge/rechallenge data, alternative causes, and biological plausibility.
Instant classification against ICH E2A seriousness criteria. The AI scans the narrative for indicators of each criterion and flags the case accordingly, ensuring no serious case slips through as non-serious.
When a case meets expedited reporting criteria, serious, unexpected, and at least possibly related, the AI immediately flags it and starts the regulatory clock. Your team gets notified instantly so no 15-day or 7-day deadline is missed.
The AI generates a complete, structured ICSR case narrative from the reporter's submission, ready for inclusion in safety database entries and regulatory submissions. Written in standard pharmacovigilance language with all required elements.
As your case database grows, the AI monitors for emerging safety signals across your portfolio, surfacing unusual patterns in event frequency, severity, or patient demographics that may indicate a new safety concern.
Here's exactly what happens in the ~30 seconds between a reporter clicking "Submit" and your PV specialist seeing a fully triaged case.
Reporter completes the 5-step intake form and hits submit
Engine reads narrative, codes MedDRA, assesses causality and seriousness
Expedited cases flagged, clock started, alerts sent to PV team
Specialist reviews AI output, approves or adjusts assessments
Approved case pushes to Veeva, Argus, or E2B export
AI in pharmacovigilance requires transparency, auditability, and human oversight. Here's how AE Connect meets those requirements.
Every AI assessment is logged with timestamp, model version, input data, output, and confidence scores. Meets 21 CFR Part 11 electronic records requirements.
No AI output reaches your safety database without explicit PV specialist approval. Every assessment is reviewable, editable, and overridable with documented rationale.
The AI shows its work, which narrative phrases drove each MedDRA code, which factors contributed to causality, why a case was flagged as expedited. No black boxes.
HIPAA-ready architecture with encryption at rest and in transit. Patient data is processed in isolated environments with no cross-tenant data exposure. SOC 2 readiness built in.
IQ/OQ documentation available for Scale and Enterprise tiers. GAMP 5 category 4/5 classification. Validation test scripts included for GxP compliance.
The model improves with each reviewed case. PV specialist corrections feed back into accuracy metrics so you can track AI performance over time.
Book a 20-minute demo and we'll run a live case through the system, from reporter submission to fully coded, triaged ICSR in under 30 seconds.