H1ST-AI-MON-003 · Task 2.3
The AE in the note that never got captured
An adverse event that lives only in a narrative note is a patient-safety risk and a compliance exposure waiting to be found. The Symptom & AE Detection Agent reads clinical notes as they're uploaded, recognizes symptom patterns like an elevated temperature, auto-detects adverse events in free text, and prompts your team to run the right assessment or AE reporting workflow within about a minute — closing the gap between a note and an action before anyone else has to find it.
The grind you know
An adverse event gets written into a visit note and then, somewhere between a busy clinic day and the EDC, never becomes a reportable AE — or becomes one weeks too late. A symptom that warranted an assessment slips past a coordinator who's stretched thin, and you don't find out until monitoring catches it, or an inspector does. Every one of those misses is a patient-safety question you'd rather never have to answer.
Part of the Risk-Based Monitoring family
Risk-based monitoring & safety oversight.
An adverse event that lives only in a narrative note is a patient-safety risk and a compliance exposure waiting to be found. The Symptom & AE Detection Agent reads clinical notes as they're uploaded, recognizes symptom patterns like an elevated temperature, auto-detects adverse events in free text, and prompts your team to run the right assessment or AE reporting workflow within about a minute — closing the gap between a note and an action before anyone else has to find it.
As source notes are uploaded, the agent reads the narrative and structured content for each visit.
Clinical pattern recognition identifies symptoms and events that meet AE criteria and classifies them by likely severity.
For each detection it prompts the appropriate assessment or AE reporting step and alerts the responsible owner within about a minute.
Capabilities
Identifies symptom patterns in narrative notes — a recorded high temperature, a lab value out of range, a described reaction — using clinical language understanding rather than keyword matching.
Scans clinical notes for described events that meet AE criteria and flags them for capture, catching events documented in narrative but not yet recorded as AEs.
When a symptom or event is detected, it prompts the appropriate next step — an AE assessment, a follow-up procedure, or initiation of the AE reporting workflow.
Runs on upload and raises alerts within about a minute, so time-sensitive safety signals reach the team while there's still time to act.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
An adverse event gets written into a visit note but never becomes a recorded AE between a busy clinic day and the EDC. The agent auto-detects the described event in the free text and prompts the AE reporting workflow within about a minute of upload.
A high temperature is documented but the assessment it warranted slips past a stretched coordinator. Clinical pattern recognition flags the symptom and prompts the appropriate next step, so the signal turns into an action while there's still time.
An inspector wants evidence that events described in narratives were assessed and captured. The reconciliation view lines up narrative events against recorded AEs, giving you clear proof of oversight under ICH E6.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Paddle OCR
OCR
Gemini / Anthropic LLM
LLM
Who it's for
Reads source documents with OCR and clinical NLP to surface review findings, each with a confidence score.
Learn moreAggregates events across sites to detect safety signals and suggests medical coding for faster review.
Learn moreRuns configurable monitoring rules and Key Risk Indicators, surfacing findings on a severity-ranked dashboard.
Learn morePeace of mind
Every output is generated inside a validated, audit-ready platform, kept under human-in-the-loop control, and mapped to the regulatory and CDISC standards this agent supports.
Walk through it on your own workflow with a clinical-trials expert — no pressure, no obligation, and honest answers, including on the limits.
