Product Specifications · Official Release · 2026

Clinical Trial Intelligence,
Engineered for the Stakes.

Three purpose-built AI products that unify clinical trial governance, data integrity, and regulatory compliance — from study start to CSR submission — in real time.

Real-TimeCompliance Monitoring

ZeroWrites to Source Systems

1Unified Source of Truth

GlobalRegulatory Coverage

ICH GCP E6(R3) 21 CFR Part 11 CDISC CDASH · SDTM eTMF Reference Model EU AI Act Compliant FDA · EMA · PMDA HIPAA · GDPR

Product 01 of 03

Aurelyn Trial | OS™

The operating system for the clinical trial lifecycle. A protocol-native, AI-powered governance layer that unifies every connected system into one continuously validated, inspection-ready compliance environment.

At a Glance

Aurelyn Trial | OS™ is the industry's first closed-loop clinical trial operating system — purpose-built for sponsors, CROs, and life sciences organizations that cannot afford the cost of clinical entropy. By treating the study protocol as executable logic and anchoring every decision to pre-loaded global regulatory standards, it transforms compliance from a retrospective audit into a proactive, real-time governance function. Built for clinical operations leaders who demand a single, unimpeachable source of truth across every trial system, site, and data point — from Day One through NDA filing.

Key Features & Benefits

Six Core Governance Pillars

Each feature is engineered around a direct operational benefit — eliminating the gap between what clinical regulations require and what trials actually deliver.

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Pillar One

Real-Time Data Ingestion & Normalization

API-driven, read-only ingestion across all connected trial systems, normalized to CDISC and eTMF Reference Model standards on every event.

Multi-system connectors→Eliminates manual reconciliation between EDC, eTMF, CTMS, Safety, and Lab systems

Schema drift detection→Catches data structure changes at ingestion — before they create false compliance flags

Temporal reconciliation→Flags gaps between event occurrence date and entry date — turning time into a compliance metric

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Pillar Two

Protocol Logic Engine & Rule Derivation

The protocol is parsed into a structured, deterministic rule set — the executable law of the trial. Human-validated before activation.

Protocol-to-logic parsing→Turns dense protocol text into enforceable rules without manual configuration per trial

Regulatory floor check→Flags lax protocol requirements before the trial starts — preventing compliance design flaws

Human sign-off workflow→Expert review and 21 CFR Part 11-compliant e-signature required before any rules go live

III

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Pillar Three

Deviation Detection & Remediation Engine

Every discrepancy is detected in real time, severity-classified, and delivered with the exact protocol section and regulatory citation violated — plus prescriptive remediation guidance.

Severity classification→Critical through Minor tiers anchored to protocol and regulatory definitions — no arbitrary prioritization

Regulatory citation output→Every flag includes the specific GCP clause, CFR section, or protocol paragraph violated

Remediation suggestions→Prescriptive action steps from regulatory guidance — moving teams from confusion to execution

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Pillar Four

Priority-Weighted Notification Engine

Notification timing and escalation are derived from the protocol and applicable regulatory reporting windows — never arbitrary, always audit-defensible.

SAE window enforcement→7/15-day expedited reporting windows trigger immediate alerts and progressive re-notification

Role-scoped notifications→CRAs, Medical Monitors, and PMs each receive only the alerts relevant to their accountability

Remediation velocity tracking→Measures time-to-resolution per issue type and site — identifying systemic bottlenecks proactively

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Pillar Five

Amendment Propagation & Version Governance

Protocol amendments are treated as active system events — triggering automated downstream impact analysis and site-level compliance enforcement.

Downstream impact analysis→Every amendment automatically generates the complete list of required ICF, IRB, and data collection adjustments

Version drift prevention→Sites operating on superseded document versions are immediately flagged — eliminating the #1 inspection finding

Protocol epoch versioning→Full lineage of every protocol version with effective dates — enabling precise historical compliance reconstruction

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Pillar Six

CSR & NDA Data Crystallization

Because compliance data is continuously structured and validated throughout the trial, CSR compilation becomes crystallization — not reconstruction.

Continuous deviation log→Deviation summary pre-structured to ICH E3 CSR format — always current, never assembled at close-out

Inspection-ready packages→On-demand export of audit-defensible documentation for regulatory inspections and submissions

CDISC submission alignment→Ingested datasets mapped to SDTM/ADaM standards — supporting high-quality regulatory submission packages

Deep-Dive Specifications

Specification	Detail	Standard / Reference	Status
Ingestion Model	Read-only, API-based, real-time. No write access to source systems.	Non-Destructive Observer	Core
Data Normalization	Canonical Data Model normalized to CDISC and eTMF Reference Model on every ingestion event	CDISC CDASH / SDTM / ADaM	Core
Protocol Parsing	ICH/FDA template-anchored structural parsing. Extracts visit schedule, time-events matrix, reporting windows, endpoint definitions, eligibility criteria	ICH E6(R3) / FDA Protocol Templates	Core
Rule Activation	All derived protocol rules require human expert review and 21 CFR Part 11 e-signature before activation	21 CFR Part 11	Mandatory
Deviation Classification	4-tier severity model: Critical / Major / Moderate / Minor — derived from protocol definitions and applicable regulations	ICH GCP / Protocol-Defined	Core
SAE Reporting Enforcement	7-day fatal/life-threatening SUSAR and 15-day all other unexpected SUSAR windows enforced with progressive re-notification	ICH E2A / 21 CFR 312.32	Critical
Audit Trail	Immutable, timestamped log of all system events. Non-modifiable by any user. Exportable for regulatory inspection.	21 CFR Part 11.10(e)	Core
Authentication	MFA mandatory. SSO via SAML 2.0 and OAuth 2.0. Unique user identification per 21 CFR Part 11	NIST SP 800-63B	Core
Encryption	AES-256 at rest. TLS 1.3 minimum in transit. End-to-end encryption across all API connector channels	NIST FIPS 140-2	Core
Validation	GAMP 5 Category 4/5 approach. Full IQ/OQ/PQ documentation package. Change control required for all modifications	GAMP 5 / 21 CFR Part 11	Required
Uptime SLA	99.9% uptime. Active-active geographic redundancy. RTO < 4 hours, RPO < 1 hour	GxP Data Integrity	Core
Regulatory Knowledge Base	Pre-loaded with ICH, FDA CFR, EMA, PMDA, CDISC, HIPAA, GDPR, EU AI Act. Controlled versioning. User-immutable.	Global Standards	Core
Deployment Model	Enterprise SaaS. Trial-isolated instances. Per-trial protocol-native configuration.	Cloud-Native	Core
EU AI Act Classification	High-risk AI system per Annex III. Full human oversight mandate. Transparency documentation included.	EU AI Act 2024/1689	Compliant
Data Privacy	Pseudonymized/de-identified subject data only. GDPR Article 89 and HIPAA Safe Harbor compliant. DPA required with all source system providers.	HIPAA / GDPR	Core

Use Cases

Where Aurelyn Trial | OS™ Excels

Use Case 01

Global Phase III Trial — Multi-Site, Multi-Region Compliance

A sponsor running a 200-site global Phase III trial across the US, EU, and Japan deploys Aurelyn Trial | OS™ at study start. The OS normalizes data from their Medidata Rave EDC, Veeva Vault eTMF, and Oracle CTMS into one compliance stream. Protocol deviations are caught within hours of entry — not surfaced in monthly monitoring reports. Each site receives targeted, role-scoped remediation instructions in real time.

Outcome: FDA pre-approval inspection completed with zero critical findings. CSR deviation table compiled in days — not months.

Use Case 02

Protocol Amendment — Eliminating Version Drift Across 80 Sites

A clinical operations team issues a major protocol amendment mid-trial — modifying the primary endpoint definition and ICF language. Aurelyn Trial | OS™ performs an automated downstream impact analysis, generating the complete list of required ICF updates, IRB submissions, and data collection adjustments. Sites are notified within hours. The OS begins monitoring each site's eTMF for receipt of the new version documents — flagging any site still operating on the prior version.

Outcome: Zero sites operating on a superseded protocol or ICF version 30 days post-amendment — a result that previously required months of CRA follow-up.

Use Case 03

CRO Operational Excellence — Real-Time Client Reporting

A CRO deploys Aurelyn Trial | OS™ across a portfolio of sponsor trials, providing each sponsor with a dedicated compliance dashboard. Clinical Project Managers use the system health view and remediation velocity metrics to proactively identify underperforming sites before they impact enrollment timelines or data quality. The automated audit trail and CSR-ready data packages dramatically reduce close-out effort for every study.

Outcome: CRO reduces average study close-out duration and delivers demonstrably superior GCP compliance metrics to sponsor clients — a differentiated competitive position.

Product 02 of 03

Clinical Evidence & Consistency Engine™

The core AI intelligence layer that turns fragmented multi-system clinical data into a single, validated, audit-defensible stream of truth — detecting every discrepancy at the moment it occurs, with the regulatory evidence to resolve it.

At a Glance

The Clinical Evidence & Consistency Engine™ is Aurelyn AI Clinical's proprietary deterministic validation core — the intelligence that sits between your disparate trial systems and the decisions your teams must make. Unlike conventional data management tools that flag errors retrospectively, the Engine operates as a continuous, real-time compliance pulse: ingesting evidence from every source system, comparing it against the protocol blueprint and pre-loaded regulatory standards, and surfacing every discrepancy with the specific citation and prescriptive remediation path already attached. Built for Data Management, Clinical Operations, and Regulatory Affairs professionals who cannot wait until a monitoring visit to discover a data integrity failure.

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Core Capability

Deterministic Protocol-vs-Evidence Validation

The Engine compares real-time evidence from all connected systems against the signed protocol rule set. Logic is derived exclusively from the protocol — no probabilistic models, no approximations.

Protocol-derived rules→Every comparison is anchored to what the protocol mandates — a single, unimpeachable source of truth

Cross-system consistency→Detects mismatches between EDC, safety, and lab data that live in separate systems — invisible to any single platform

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Core Capability

Temporal Compliance Enforcement

Every time-sensitive protocol and regulatory requirement is monitored with millisecond precision — from SAE reporting windows to visit assessment timelines to ICF consent sequencing.

Event-to-entry gap detection→Flags late EDC entries before they become reportable regulatory delays

Regulatory window tracking→ICH E2A 7/15-day SAE windows enforced in real time with elapsed-time escalation

III

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Core Capability

Regulatory Citation Engine

Every flag produced by the Engine includes the specific protocol section, regulatory clause, and ICH/CFR reference that is violated — pre-packaged for immediate human review and audit defense.

Auto-mapped citations→Eliminates hours of manual regulatory reference lookup per deviation event

Remediation suggestions→Prescriptive resolution steps derived from regulatory guidance — not generic system alerts

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Core Capability

Multi-System Ingestion & Schema Validation

Purpose-built connectors for each major trial system ingest data in real time, validate it against the canonical data model, and detect structural drift before it enters the consistency layer.

System-specific connectors→High-fidelity ingestion from EDC, eTMF, CTMS, Safety, IVRS, Lab, and Regulatory platforms

Schema drift alerts→API structural changes flagged at detection — preventing false compliance signals from bad data mapping

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Core Capability

Action Queue & Team Accountability Layer

Detected discrepancies become structured action items assigned to the responsible party — in the dashboard and via automated email — with severity-weighted timelines tied to regulatory requirements.

Auto-assigned actions→Responsible party identified at detection — eliminating the "who owns this?" bottleneck in remediation

Auto-close on resolution→When a correction is confirmed in the source system, the Engine closes the action — no manual logging

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Core Capability

Human-Validated AI Governance

The Engine operates as an intelligence navigator — not an autonomous decision-maker. Human review is mandatory at every critical gate: rule activation, amendment sign-off, and deviation classification oversight.

Human-in-the-loop mandate→Meets EU AI Act High-Risk system requirements and preserves regulatory accountability within the human domain

Dual-layer validation→Rules reviewed before activation; outputs reviewed before remediation — systemic errors caught before they propagate

Deep-Dive Specifications

Specification	Detail	Standard / Reference	Classification
Validation Logic Model	Deterministic — derived exclusively from protocol and regulatory standards. No probabilistic inference on clinical outcomes.	Protocol-Native	Core Design
Ingestion Frequency	Real-time via webhook or API polling. Configurable minimum polling interval per system criticality.	Real-Time	Core
Deviation Types Detected	Temporal, data integrity, eligibility, documentation, procedural, safety reporting — 6 primary deviation categories	ICH GCP Deviation Framework	Core
Severity Tiers	Critical / Major / Moderate / Minor — derived from protocol definitions and applicable regulatory requirements	Protocol-Defined	Core
Regulatory Knowledge Base	ICH GCP E6(R3), 21 CFR 312/50/54/11, EMA GCP Directive, PMDA, ICH E2A/E3/E9, MedDRA, CDISC CDASH/SDTM/ADaM, HIPAA, GDPR, EU AI Act	17+ Standards Pre-Loaded	Immutable
Citation Output	Every deviation includes: protocol section, regulatory clause, evidence comparison (expected vs. actual), remediation guidance	ALCOA+ Principles	Core
SAE Window Enforcement	7-day (fatal/life-threatening SUSAR), 15-day (all other unexpected SUSAR), protocol-defined timelines for non-expedited events	ICH E2A / 21 CFR 312.32	Critical
Action Assignment	Responsible party auto-identified based on role mapping and protocol delegation at detection. Escalation chain protocol-defined.	ICH GCP Delegation	Core
Action Resolution	Auto-close triggered when correction confirmed in source system via real-time ingestion. Resolution timestamp logged.	Automated	Core
Protocol Epoch Versioning	Every amendment creates a new logical epoch. Prior epoch data preserved with full lineage — not retroactively altered.	Data Integrity / 21 CFR 11	Required
Data Integrity Standard	ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate. Data hashing at ingestion to detect tampering.	FDA Data Integrity Guidance 2018	Core

Use Case 01

Late SAE Reporting Prevention — A Critical Safety Window

A site enters a serious adverse event in the EDC 48 hours after occurrence. The Engine detects the event date vs. entry date gap within minutes of the EDC entry. An immediate Critical severity alert is sent to the Medical Monitor and CRA, with the ICH E2A 7-day reporting window and current elapsed time displayed. The site receives a prescriptive email outlining the specific regulatory reporting obligation and required actions.

Outcome: Regulatory authority notified within the mandated window. The deviation is documented, remediated, and closed before it compounds — not discovered at a quarterly monitoring visit.

Use Case 02

Cross-System Data Mismatch — EDC vs. Safety System

A subject experiences an adverse event recorded in the EDC with a severity of "Moderate." The same event is entered in the pharmacovigilance system with a severity of "Severe." The Engine detects the cross-system severity discrepancy in real time and generates a Major severity flag for the Data Manager and Clinical Lead, including the specific protocol section requiring consistent severity grading and the regulatory implications of the mismatch.

Outcome: Data discrepancy resolved within 24 hours. The NDA submission dataset reflects consistent, reconciled severity data — with a full audit trail of the detection and resolution.

Use Case 03

Pre-Trial Protocol Compliance Gap — Regulatory Floor Check

At study start, the Engine parses the protocol and identifies a subject follow-up requirement that falls below the minimum standard specified in ICH E6(R3) Section 5.18. Before the trial activates, the Engine flags the lax requirement with the specific regulatory citation and a remediation suggestion. The clinical lead documents the override rationale or initiates a protocol amendment — before a single subject is enrolled.

Outcome: A potential GCP inspection finding is caught and resolved before it is baked into the study design — the highest-value compliance intervention possible.

Product 03 of 03

eTMF Intelligence OS™

The first operational intelligence layer built specifically for the electronic Trial Master File — transforming the eTMF from a passive document archive into a real-time, continuously monitored compliance system.

At a Glance

The eTMF Intelligence OS™ solves one of the most persistent failures in clinical trial conduct: the eTMF as a static database that teams fill reactively and regulators critique retroactively. Aurelyn AI Clinical's eTMF Intelligence OS™ maps every expected document artifact against the eTMF Reference Model, monitors completeness in real time, tracks expirations and missing signatures across every site and zone, and enforces version currency — ensuring that every site, at every moment, is operating on the correct approved documents. Built for Regulatory Affairs, Clinical Operations, and Quality teams who need their eTMF to be inspection-ready not at close-out, but always.

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Core Capability

Real-Time eTMF Completeness Monitoring

Every expected document artifact per the eTMF Reference Model is mapped and monitored continuously. Gaps surface immediately — not at close-out or during a regulatory inspection.

Zone-level completeness→Missing documents flagged by eTMF Reference Model zone, section, and site — with the specific artifact and GCP requirement cited

Site-level gap analysis→Per-site eTMF health score enables targeted remediation — so CRAs know exactly which site needs what

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Core Capability

Signature Status Tracking & Escalation

All documents requiring investigator, sponsor, or CRO signatures are tracked continuously. Missing or pending signatures generate action items with responsible party identification and the specific GCP signature requirement.

Pending signature alerts→Documents awaiting signature are surfaced before they become delinquent — not discovered during inspection

Escalation workflow→Unresolved signature gaps escalate through the accountability chain based on protocol-defined timelines

III

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Core Capability

Document Expiration Monitoring

Time-sensitive documents — investigator CVs, GCP training certificates, financial disclosures, regulatory approvals, IRB/IEC approvals — are monitored against expiration dates with tiered advance alerts.

Configurable alert horizons→90/60/30-day pre-expiration alerts ensure renewals are initiated before documents lapse — keeping sites continuously eligible

Regulatory citation→Every expiration alert includes the GCP requirement for currency of that specific document type

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Core Capability

Document Version Currency Enforcement

The most common and most serious GCP inspection finding — sites operating on superseded protocol, ICF, or supporting document versions — is detected and flagged in real time.

Version cross-referencing→Each site's filed documents are continuously compared against current approved versions — across every zone and site simultaneously

Amendment-triggered checks→Every protocol amendment triggers an immediate re-verification of version currency across all active sites

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Core Capability

ICF Version Compliance Across All Sites

Informed Consent Form version management is among the highest-risk compliance domains in clinical trials. The eTMF Intelligence OS™ monitors ICF version currency at every active site — flagging any subject consented on a superseded form.

ICF version tracking→Immediate flag when a site is using a prior ICF version post-amendment — one of the most common FDA 483 observations

Re-consent triggers→Protocol-required re-consent activities are surfaced as action items with the regulatory basis and required timeline

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Core Capability

Inspection-Ready eTMF Export Package

At any point in the trial — not only at close-out — the eTMF Intelligence OS™ can generate a structured inspection-readiness report: completeness status, gap analysis, and remediation history — mapped to the eTMF Reference Model.

On-demand readiness report→Regulatory inspectors see a complete, structured eTMF status — not a frantic close-out assembly

Full remediation history→Complete audit trail of every gap detection and resolution — demonstrating ongoing quality management, not reactive cleanup

Deep-Dive Specifications

Specification	Detail	Reference Standard	Classification
eTMF Standard	TMF Reference Model v3.x — complete zone and artifact mapping for all expected trial documents	eTMF Reference Model	Core
Monitoring Mode	Real-time continuous monitoring via read-only eTMF platform API. No document modification capability.	Non-Destructive Observer	Core
Completeness Scope	Zone-level, section-level, and site-level completeness tracking. Expected artifacts per eTMF Reference Model mapped per trial type.	eTMF Ref Model Zones 1–16	Core
Signature Monitoring	Investigator, sponsor, CRO, and IRB signatures tracked. Missing/pending signatures flagged with responsible party and GCP citation.	ICH GCP E6(R3) / 21 CFR 312	Core
Expiration Alert Horizons	Configurable: 90-day, 60-day, 30-day, and at-expiration alerts. Document-type-specific alert logic.	ICH GCP / Protocol-Defined	Core
Document Types Monitored	Investigator CVs, GCP certifications, financial disclosures, regulatory approvals, IRB/IEC approvals, informed consents, delegation logs, monitoring reports, laboratory certifications, and all protocol/amendment documents	eTMF Reference Model	Core
Version Enforcement	Each site's filed documents continuously compared against the current approved version. Amendment-triggered re-verification across all sites.	ICH GCP / 21 CFR 312.62	Core
ICF Version Tracking	Consent form version monitored per site and per subject cohort. Flags any site or subject on a superseded ICF post-amendment.	21 CFR Part 50 / ICH GCP	Critical
Inspection Export	On-demand inspection-readiness report: completeness status, gap log, remediation history, audit trail — mapped to eTMF Reference Model structure.	eTMF Reference Model / GCP	Feature
Platform Integrations	Compatible with leading eTMF platforms via read-only API. Platform-agnostic design — no proprietary system lock-in.	API-Native	Core
Audit Trail	Immutable log of all gap detections, alert transmissions, acknowledgments, and resolutions. Timestamped to source system ingestion.	21 CFR Part 11.10(e)	Core
Role-Based Access	CRA, Regulatory Affairs, Clinical Lead, QA, and Site Coordinator views — each scoped to relevant eTMF domains and sites	RBAC / 21 CFR Part 11	Core

Use Case 01

FDA Pre-Approval Inspection — eTMF Readiness on Demand

Three weeks before a scheduled FDA pre-approval inspection, a sponsor's Regulatory Affairs team requests an eTMF readiness report from the eTMF Intelligence OS™. The report surfaces four sites with pending investigator CV renewals and two sites with an outdated GCP training certificate. Targeted remediation actions are assigned to CRAs for immediate resolution. When the inspection begins, the eTMF is complete and fully current.

Outcome: Zero eTMF-related inspection observations. The FDA inspector receives a complete, organized eTMF — demonstrating a culture of ongoing quality management rather than reactive pre-inspection cleanup.

Use Case 02

Mid-Trial ICF Amendment — Site Currency Across 60 Sites

A protocol amendment requires an updated ICF to be implemented at all 60 active sites. The eTMF Intelligence OS™ begins monitoring receipt of the new ICF at every site immediately upon amendment activation. Sites that have not filed the new ICF within the protocol-defined implementation window are flagged, and their CRAs receive targeted follow-up actions. The OS tracks each subject's consent form version — flagging any subject consented on the old form after the new version's effective date.

Outcome: Full ICF version compliance across all sites achieved within the protocol-required window. Zero subjects on a superseded consent form — eliminating one of the highest-risk inspection findings in clinical operations.

Use Case 03

CRO Quality Operations — Portfolio-Wide eTMF Health

A CRO uses the eTMF Intelligence OS™ across a portfolio of 12 active trials, giving their Quality team a real-time view of eTMF health across all studies simultaneously. The system's per-trial, per-site completeness scores and expiration alerts allow one QA manager to maintain oversight of documentation quality across the full portfolio — work that previously required dedicated site-level manual review for every study.

Outcome: CRO achieves portfolio-wide eTMF quality oversight with a fraction of the manual effort — delivering demonstrably superior documentation quality to sponsor clients and reducing close-out timelines across all studies.

At Sign-Up

What's Included

Every Aurelyn AI Clinical enterprise deployment is delivered as a production-grade, validated environment — complete with the regulatory infrastructure, integration support, and human expertise your trial demands from Day One.

Aurelyn AI Clinical — Enterprise Deployment Package

Available per product or as a unified Clinical Governance Suite

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Configured Trial Instance

A dedicated, isolated trial environment pre-loaded with the applicable global regulatory standards and ready for protocol onboarding. One instance per trial.

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Protocol Onboarding & Rule Derivation Service

Aurelyn AI Clinical specialists support protocol loading, structured parsing, and preparation of the derived rule set for human expert review and sign-off.

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API Connector Configuration

Purpose-built connectors configured for all contracted source systems (EDC, eTMF, CTMS, Safety, IVRS, Lab) with schema validation and drift monitoring active from go-live.

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Validation Documentation Package

GAMP 5-compliant IQ/OQ/PQ protocols and reports, traceability matrix, and system validation summary — ready for sponsor and regulatory review.

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Regulatory Knowledge Base (Pre-Loaded)

17+ global regulatory standards, ICH guidelines, CDISC data models, and eTMF Reference Model — pre-configured, versioned, and immutable within the system.

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Role-Based User Training Program

Structured onboarding for all user roles: Clinical PM, CRA, Medical Monitor, Data Manager, Regulatory Affairs, QA, and Site Coordinator. Includes training documentation for 21 CFR Part 11 training records.

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Compliance Dashboard — All Role Views

Production-configured dashboards for every role: Trial Health Overview, Action Queue, eTMF Health Monitor, Deviation Analytics, Data Collection Status, Amendment Tracker.

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System SOPs & User Documentation

Ready-to-adopt standard operating procedures covering system access, protocol onboarding, amendment management, deviation response, and audit trail review.

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Dedicated Implementation Specialist

A named Aurelyn AI Clinical specialist assigned for the duration of study start-up — supporting connector configuration, team onboarding, and first-use validation.

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Enterprise Security & Compliance Configuration

MFA, RBAC, SSO integration, AES-256 encryption, TLS 1.3 transit security, 21 CFR Part 11-compliant e-signature and audit trail — active from Day One.

Intellectual Property & Legal Notice

Aurelyn Trial | OS™, Clinical Evidence & Consistency Engine™, and eTMF Intelligence OS™ are proprietary products of Aurelyn AI Clinical, operated by Aurelyn AI. All product names, methodologies, system architectures, data processing frameworks, Regulatory Knowledge Base structures, and associated documentation are the exclusive intellectual property of Aurelyn AI Clinical.

Access to and use of Aurelyn AI Clinical products is governed by an executed Enterprise License Agreement and subject to the Aurelyn AI Clinical Terms of Use. Unauthorized use, reproduction, reverse engineering, redistribution, or creation of derivative works is strictly prohibited and may result in civil and criminal liability under applicable intellectual property law.

All client data processed through Aurelyn AI Clinical products remains the sole property of the contracting organization. Aurelyn AI Clinical processes such data as a data processor under the terms of an executed Data Processing Agreement in compliance with GDPR (EU) 2016/679 and HIPAA (45 CFR Parts 160 and 164).

For full terms of use, please visit: aurelynaiclinical.org/legal/terms
For privacy policy: aurelynaiclinical.org/legal/privacy
For licensing inquiries: legal@aurelynaiclinical.org

ℹ️

Product specifications are subject to change. Features, integrations, and regulatory coverage described in this document reflect the current product version. Aurelyn AI Clinical reserves the right to update product specifications, regulatory knowledge base content, and feature availability. Enterprise clients will be notified of material changes per the terms of their license agreement. All regulatory standards referenced are current as of document date; updates to those standards are incorporated into the Regulatory Knowledge Base via Aurelyn AI Clinical's controlled versioning process.

Ready to Govern Your Trial in Real Time?

One Source of Truth.
Every Trial. Every Site.

From study startup through NDA submission — Aurelyn AI Clinical ensures your clinical evidence is continuously validated, inspection-ready, and structurally sound.

Request a Demo Contact Our Team

Aurelyn Trial | OS™ Clinical Evidence & Consistency Engine™ eTMF Intelligence OS™

Clinical Trial Intelligence, Engineered for the Stakes.

Aurelyn Trial | OS™

Six Core Governance Pillars

Deep-Dive Specifications

Where Aurelyn Trial | OS™ Excels

Clinical Evidence & Consistency Engine™

Deep-Dive Specifications

eTMF Intelligence OS™

Deep-Dive Specifications

What's Included

One Source of Truth.Every Trial. Every Site.

Clinical Trial Intelligence,
Engineered for the Stakes.

One Source of Truth.
Every Trial. Every Site.