Data Management & Oversight · H1ST-AI-MON-003
Risk-based monitoring & safety oversight.
The problem this family owns
This is the stretch of the trial where the work is repetitive, deadline-bound, and unforgiving of small errors — the part a stretched team feels first, and the part where a missed detail is most expensive to fix later.
The Risk-Based Monitoring family puts a purpose-built agent on each of these. You stay in control of every output — the agents absorb the grind, not the judgment.
Where it fits
Continuous, centralized oversight. Risk-Based Monitoring reviews source documents, detects symptoms and adverse events, surfaces safety signals, and tracks key risk indicators against ICH E6(R3) thresholds.
It sits in the Data Management & Oversight suite — clean data and continuous oversight, in real time — and is delivered as 4 individually-deployable AI agents you can adopt one at a time or as a complete workflow.
The agents
Each agent below removes a specific piece of that grind. Deploy the whole family as one workflow, or add the single agent that hurts most today and expand from there.
Reads source documents with OCR and clinical NLP to surface review findings, each with a confidence score.
Learn moreRecognizes 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 moreOne workflow, not point tools
Enabled together, the Risk-Based Monitoring agents hand off in sequence — each one's output becomes the next one's input, so nothing is re-keyed and nothing falls between the seams.
Reads source documents with OCR and clinical NLP to surface review findings, each with a confidence score.
Recognizes symptoms and adverse events in clinical notes and prompts the right assessment before they're missed.
Aggregates events across sites to detect safety signals and suggests medical coding for faster review.
Runs configurable monitoring rules and Key Risk Indicators, surfacing findings on a severity-ranked dashboard.
Built for regulated trials
Every agent runs inside a validated, audit-ready platform aligned to the standards clinical teams and inspectors expect.
Electronic records and signatures with full audit trails, access controls, and validation.
Good Clinical Practice, including risk-based quality management and computerized-system expectations.
Standards-based data capture, tabulation, and analysis datasets that validate clean in Pinnacle 21.
PHI safeguards, de-identification, and role-based access across the platform.
Lawful processing, data-subject rights, and EU data-residency support for global trials.
Security, availability, and confidentiality controls audited against Trust Services Criteria.
Certified information-security management system governing the whole platform.
AI management system for responsible, governed, and auditable use of AI.
Straight answers
Pulled from the questions teams ask most about the agents in this family — answered plainly, including where the honest answer is a limit.
No pitch, no pressure — a working walkthrough on your own workflow and honest answers, including on the limits. Bring the study that worries you most.
