Aurelyn AI Clinical Trial | OS™
A unified AI intelligence layer — continuously monitoring, classifying, synthesizing, and cross-validating every document and data point across your clinical trial from first patient enrolled to regulatory submission.
Clinical Trials Drown in
Disconnected, Inconsistent Data
Sponsors and global CROs manage dozens of systems and hundreds of documents with no unified intelligence layer — and no systematic check that those documents tell one coherent regulatory story.
Fragmented eTMF Management
Documents expire, signatures go missing, and audit findings accumulate because manual review cannot keep pace with multi-site trials across geographies and timelines.
No Real-Time Evidence Synthesis
Clinical evidence — endpoints, safety signals, efficacy data — lives in isolated systems. Teams cannot synthesize findings fast enough to inform protocol amendments or submission strategies.
Cross-Document Inconsistencies
Protocol definitions, SAP endpoints, CSR narratives, and CRF annotations frequently contradict each other — invisible until a regulator flags them post-submission.
Three Purpose-Built AI Engines.
One Single Source of Truth.
Each engine addresses a distinct operational failure mode. Together they form an integrated intelligence layer that eliminates the fragmented, manual workflows costing sponsors and CROs millions per trial.
Aurelyn AI eTMF Intelligence Engine™
Built on the CDISC eTMF Reference Model, continuously reading, classifying, and monitoring every document across every site — eliminating the backlog before it begins and delivering predictive audit readiness at scale.
- ✓AI-driven auto-classification against CDISC zones, sections, and artifacts — no manual indexing
- ✓Continuous monitoring for expired documents, missing signatures, and audit-critical gaps
- ✓Site-specific email templates at configurable intervals — one-click forward or auto-send
- ✓Predictive audit readiness scoring by site, country, and study
- ✓Real-time TMF Completeness Index dashboard with drill-down to artifact level
Aurelyn AI Clinical Evidence Engine™
Aggregates and synthesizes clinical evidence from across the full trial tech stack — surfacing signals, trends, and actionable insights in real time for medical, regulatory, and operational decision-makers.
- ✓Automated endpoint analysis: primary and secondary outcome measures tracked continuously
- ✓Safety signal detection with severity-weighted alerting and auto-narrative generation
- ✓Evidence synthesis across EDC, central labs, safety DB, and literature — unified in one view
- ✓Protocol deviation pattern recognition with root-cause clustering
- ✓Submission-ready evidence packages auto-assembled per FDA, EMA, and PMDA requirements
Clinical Evidence Consistency Engine™ (CECE)
The industry's first AI-powered cross-document validation and reconciliation engine. CECE systematically cross-references every claim, data point, endpoint definition, and procedural description across all trial documents — detecting contradictions and misalignments before they reach a regulator or auditor.
- ✓Endpoint consistency validation across Protocol, SAP, CRF annotations, and CSR
- ✓Cross-document claim tracing — every assertion traced from CSR back to source data
- ✓Safety signal reconciliation across AE data, MedDRA coding, narratives, and ICF disclosures
- ✓Protocol amendment propagation — auto-flags all downstream documents requiring updates
- ✓Regulatory narrative alignment validation across eCTD modules vs. data of record
- ✓Pre-submission discrepancy report with severity classification and recommended resolutions
"Clinical evidence is not a collection of independent documents — it is a single interconnected evidentiary narrative, and any internal contradiction undermines the regulatory defensibility of the entire submission."
The Unified Intelligence
Trial | OS™ Architecture
All three engines connect through a single AI core integrated with your existing trial tech stack. Hover the nodes to explore each layer of the intelligence stack.
Built for Inspection,
Not Remediation
Every feature, every data flow, every AI decision is designed to satisfy the most demanding regulatory requirements from day one — compliance is a foundational design principle, not an afterthought.
Electronic Records & Signatures
Validated systems, complete audit trails, authority checks, and legally binding electronic signatures with biometric or knowledge-based authentication.
Good Clinical Practice
Documentation workflows enforce GCP requirements for essential document management, investigator oversight, and sponsor monitoring — with automated prompts for missing artifacts.
Protected Health Information
AES-256 encryption at rest and in transit, automated PHI detection and de-identification, role-based access controls, and BAA-ready infrastructure.
Multi-Authority Submission
Evidence outputs conform to eCTD structure requirements across FDA, EMA, and PMDA. Validation engines verify artifact completeness against authority-specific specifications.
Privacy by Design
Data minimization, purpose limitation, and consent management embedded into every pipeline. Cross-border transfers comply with EU Standard Contractual Clauses.
Data Interoperability
Native CDASH, SDTM, ADaM, and Define-XML support ensures datasets flow cleanly between collection, analysis, and submission — eliminating transformation errors.
Ready to Operate at
A Different Level of Intelligence?
Schedule a confidential platform briefing with our partnerships team. We will walk through your current trial technology stack, identify integration opportunities, and demonstrate how Trial | OS™ delivers a single source of truth — from first patient enrolled through regulatory submission.