H1ST-AI-MON-003 · Task 2.3
Your monitors are reviewing blind and sampled
When review is sampled and slow, the finding you miss is the one that surfaces at the worst possible time. The Source Document Review Agent applies OCR and a clinical language model in the BioBERT/ClinicalBERT family to read every source document the way a monitor does — spotting inconsistencies, transcription mismatches, and undocumented events — and attaches a confidence score to each finding, so your monitors spend their limited hours where it actually matters instead of reviewing blind.
The grind you know
Your monitors sit with source documents and read them line by line against the CRF, on-site or remote, with only so many hours per subject. So you sample instead of covering everything, what gets caught depends on who happened to review it, and the issues that matter most tend to surface late in the cycle — when they're hardest to unwind.
Part of the Risk-Based Monitoring family
Risk-based monitoring & safety oversight.
When review is sampled and slow, the finding you miss is the one that surfaces at the worst possible time. The Source Document Review Agent applies OCR and a clinical language model in the BioBERT/ClinicalBERT family to read every source document the way a monitor does — spotting inconsistencies, transcription mismatches, and undocumented events — and attaches a confidence score to each finding, so your monitors spend their limited hours where it actually matters instead of reviewing blind.
Provide native or scanned source files; OCR converts image-based documents into readable text.
The model interprets the clinical content, checks it against the CRF, and identifies discrepancies and undocumented items.
Findings arrive scored, letting monitors act on high-confidence issues and route the rest for human judgment.
Capabilities
Reads scanned and native source documents with Paddle OCR, then applies a ClinicalBERT-style model to interpret clinical language, abbreviations, and context.
Compares source content against corresponding CRF entries to flag transcription mismatches, missing documentation, and values that don't reconcile.
Assigns a calibrated confidence score to each finding so monitors triage high-certainty issues first and dismiss noise quickly.
Reviews every uploaded source document rather than a sample, giving centralized monitoring full-population visibility ahead of on-site visits.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
With limited monitor hours per subject, you sample source review and accept that coverage depends on who reviewed what. The agent reads every uploaded source document, giving centralized monitoring full-population visibility ahead of the on-site visit.
A value on the CRF doesn't quite match what the source note says, and that kind of mismatch is easy to miss line by line. Source-to-CRF consistency checks flag the discrepancy, so it surfaces early rather than at the worst possible time.
A long list of potential issues is only useful if you know where to start. Each finding carries a calibrated confidence score, so your monitors act on high-certainty flags first and dismiss the noise quickly instead of reviewing blind.
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
Recognizes symptoms and adverse events in clinical notes and prompts the right assessment before they're missed.
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.
