Oncology trial recruitment
Matches patients to biomarker- and stage-specific protocols where eligibility is dense.
Clinical Intelligence Agent
Clinical Trial Matching AI
An agent that reads a patient's FHIR record, evaluates it against structured trial eligibility criteria, and returns a ranked, evidence-linked shortlist — so coordinators confirm matches instead of screening charts by hand.
Coordinator-reviewedFHIR R4Explainable criteriaAudit Logged
Trusted by global innovators
The manual burden today
Trial enrollment is the research bottleneck: coordinators screen charts by hand against dense inclusion/exclusion criteria, one patient and one protocol at a time, so most eligible patients are never found. The agent does first-pass screening at scale — it encodes each trial's eligibility as structured FHIR criteria, reads the patient's record, and evaluates fit criterion by criterion, returning a ranked met/unmet/unknown shortlist with links to the data. A coordinator confirms every candidate before outreach; the agent screens, it does not enroll.
Architecture
See how the matching agent reads FHIR patient data, evaluates against ResearchStudy eligibility criteria, and produces a coordinator-reviewed shortlist with an audit trail.
Key Capabilities
Criterion-by-criterion eligibility matching on structured and unstructured data — explainable and coordinator-gated.
Eligibility matching
Evaluates a patient against each inclusion and exclusion criterion and returns met / unmet / unknown per criterion — not an opaque yes-or-no.
FHIR ResearchStudy criteria
Represents trials as FHIR ResearchStudy with structured eligibility, so protocols are machine-checkable and reusable across sites, not trapped in a PDF.
NLP for unstructured notes
Extracts stage, biomarker status, ECOG performance, and prior therapy from clinical notes so criteria in narrative text are still evaluable.
Ranked, explained, gated
Ranks candidate trials per patient with the criteria met and supporting data; every match is a candidate a coordinator confirms before outreach.
Where it runs
Deployment scenarios
Site feasibility
Estimates how many patients could qualify for a protocol before the study opens.
Cohort screening
Runs a new protocol's criteria across the population via bulk FHIR.
Coordinator pre-screening
Hands coordinators a ranked, explained shortlist so review starts from candidates, not raw charts.
Expected impact
Directional — depends on protocol complexity and data quality.
At scale
First-pass screening across the eligible population
Per-criterion
Every match shows met / unmet / unknown with evidence
Human-gated
Coordinator confirms eligibility before any outreach
Compliance-First Healthcare App Development Services Backed by Global Standards
15-Minute Scoping Call01
HIPAA
Health Insurance Portability and Accountability Act
Protect PHI with privacy-first architecture, encrypted storage and transmission, strict access controls, and traceable audit logs.
02
GDPR
General Data Protection Regulation
Implement lawful consent flows, data minimization, retention controls, and secure processing for sensitive health data.
03
FHIR
Fast Healthcare Interoperability Resources
Enable standardized health data exchange across apps, care teams, and systems through robust FHIR-ready APIs.
04
HL7
Health Level Seven International
Support enterprise-grade interoperability with HL7-based integrations for records, events, and clinical messaging workflows.
05
HITRUST
Health Information Trust Alliance
Align security programs to healthcare-specific control and risk management practices trusted by providers and ecosystem partners.
06
HITECH
Health Information Technology for Economic and Clinical Health Act
Design with breach notification readiness, digital record safeguards, and operational controls that support regulated care programs.
07
SaMD
FDA Software as a Medical Device
Plan software quality, traceability, and documentation pathways for products that may require SaMD review and submission.
08
MDR (EU)
Medical Device Regulation (European Union)
Prepare EU market-ready processes for risk classification, evidence tracking, and lifecycle governance under MDR expectations.
09
SAMHSA
Substance Abuse and Mental Health Services Administration
Apply confidentiality controls and consent-aware sharing models for behavioral and mental health data experiences.
Standards we build against
Standards & interoperability
FHIRBulk FHIRHIPAAGCPSNOMED
How It Works
From protocol to a reviewed shortlist
Structured criteria and FHIR patient data in, per-criterion evaluation with guardrails, a coordinator-reviewed shortlist, and a logged screening record.
1.
Capture — criteria + FHIR data
Trial eligibility is encoded as structured criteria (FHIR ResearchStudy), and the agent reads the patient's FHIR record plus NLP-extracted facts from notes.
FHIR R4 + NLP
2.
Processing — evaluate + guardrails
Each criterion is evaluated met / unmet / unknown; unknowns are surfaced honestly rather than assumed, and low-confidence NLP extractions are flagged for review.
Explainable matching
3.
Action — coordinator-reviewed shortlist
A ranked shortlist is presented with per-criterion evidence; a coordinator or investigator confirms eligibility and consent — the agent proposes, the human enrolls.
Coordinator-in-the-loop
4.
Write-back — screening record + audit
The screening result, matched criteria, and coordinator decision are recorded and logged to an immutable audit trail for regulatory and monitoring needs.
Audit logged
Related proof
Read Case StudyLera Health: compliant women's health platform
Related proof of compliant, AI-assisted delivery — not this exact agent. Lera Health shows how we build FHIR-native data pipelines and compliant AI workflows that turn clinical data into structured output.
Compliance & Guardrails
15-Minute Scoping CallScreening that respects consent and the record
Research touches PHI, consent, and regulatory scrutiny. The guardrails are non-negotiable.
PHI handling
Screening runs inside your compliance boundary under a BAA, encrypted throughout, scoped to authorized research staff and IRB-aligned data use.
Coordinator-in-the-loop
The agent produces candidates, not enrollments. A coordinator confirms eligibility and obtains consent before any patient is contacted.
Explainability
Every match shows which criteria are met, unmet, or unknown and the data behind each.
Audit logging
Screening decisions, matched criteria, and coordinator actions are logged immutably — the record trial monitoring and audits require.
Frequently Asked Questions
Yes — screening runs inside your compliance boundary under a BAA, encrypted throughout, scoped to authorized research staff, with every decision audit-logged.
Ready to fill your trials faster?
Tell us your protocols and EHR. We'll return an architecture review and a plan to encode eligibility and validate matching before it touches recruitment.
contact@agnotic.com
Partnerships
contact@agnotic.com