Precision intelligence for clinical research

The clinical trial,fully automatedend to end.

Thoreon Research Ai runs interim monitoring visits, reads and reconciles study documents, and keeps sponsors, CRAs and sites aligned.

HIPAA compliant/21 CFR Part 11/ICH-GCP E6 (R3)/SOC 2 Type II
IMV Session · PROTOCOL TRN-402Agent running
Source data verification · 184 fieldsComplete
Informed consent audit · 26 subjectsComplete
Deviation triage · drug accountability logNeeds CRA sign-off
Monitoring report draftQueued
Visit time saved
14.5 hrs of 18 hrs scoped

One platform for the operational weight of a trial

Clinical research requires precision, accountability and rigorous oversight. Every module produces structured, auditable output — never an unreviewed answer.

Autonomous IMV

Remote and on-site interim monitoring visits scoped, executed and reported by agents — SDV, consent audits, deviation triage, and a drafted monitoring report.

Risk-based scope · CRA checkpoints

Document intelligence

Protocols, consent forms, lab certs, CVs and delegation logs parsed against the TMF index — expiries, version drift and missing signatures surfaced before a finding becomes one.

Extraction · reconciliation · citation

Trial operations

Visit scheduling, subject follow-up, query resolution, site communication and sponsor reporting run on one timeline, so status is a live state instead of a weekly ask.

EDC / CTMS / eTMF connectors
AI-assisted IMV

A monitoring visit that starts before the CRA opens the laptop

The agent prepares the visit from the risk profile of the site, works the source data, and hands the CRA a reviewed queue instead of a blank checklist. Judgement stays human; the labour does not.

01 — SCOPE
Risk signals, enrolment velocity and prior findings define what this visit must cover.
02 — VERIFY
Source-to-EDC comparison across every critical variable, with the discrepancy cited to the page.
03 — VALIDATE
Anything material stops at a human checkpoint. The CRA confirms, edits or rejects — and that decision is logged.
04 — REPORT
Follow-up letter, action items and sponsor-ready monitoring report generated in the study's own template.
Findings queue · Site 1183 awaiting validation
findings queue — product shot1040 × 600 · dark module
184
fields verified
7
findings raised
100%
audit-trailed
Remote IMV

Runs between visits, not just during

Continuous review of newly entered data means the on-site day handles judgement, not backlog.

Traceability

Every finding cited to its source page

Open the discrepancy and see the source document, the EDC field and the rule that flagged it.

Escalation

Safety signals never sit in a queue

Potential SAEs, consent gaps and IP accountability breaks route immediately to the named monitor.

SDV COVERAGE
Risk-based or 100% — set per critical variable, not per site by habit.
CONSENT AUDIT
Version, date order and signature completeness checked per subject.
IP ACCOUNTABILITY
Dispensing logs reconciled against shipment and return records.
REPORT TURNAROUND
Draft ready at visit close; signed off inside the sponsor's SLA.

Built for everyone the protocol touches

One record of truth, four different views of it.

Sponsor

Portfolio-level oversight without chasing a status call

Live risk posture across every site, with the evidence behind each number one click away — and no waiting on a monitoring report cycle to know where a study stands.

What they get
  • Cross-site risk dashboard refreshed as visits complete
  • Monitoring reports in your own template, sponsor-ready
  • Deviation and query trends with root-cause grouping
  • Inspection-ready audit trail exportable on demand
Compliance by construction

HIPAA-compliant handling of every subject record

PHI is minimised at ingest, encrypted in transit and at rest, and never used to train models. Access is role-scoped, and every automated action is written to an immutable, inspection-ready audit trail.

Request the security brief
HIPAA & BAA
Business associate agreements, PHI minimisation, de-identified processing by default.
21 CFR Part 11
Validated workflows, e-signature integrity, versioned records with reason-for-change.
Human validation
No finding, query or report reaches a sponsor without a named human confirming it.
GDPR & regional residency
Data residency per region, retention policies aligned to the study's archival plan.
72%
less CRA time per interim monitoring visit
3 days
median finding-to-resolution across sites
100%
of automated actions human-validated and logged
0
subject records used for model training

Run your next IMV with Thoreon

Bring one protocol. We’ll run a scoped IMV alongside your team and show you the audit trail.