Aurelyn AI Clinical | AI-Powered Clinical Research Platform

The Platform

Three Engines. One Platform.

Each engine targets a distinct operational challenge in clinical research. Together, they deliver end-to-end AI intelligence across the trial lifecycle.

⬡ Clinical Trial OS

The Intelligent Clinical Trial Operating System

A unified AI command center for orchestrating every phase of a clinical trial — from study setup and site activation to risk monitoring and database lock. Replaces fragmented spreadsheets and siloed systems with one intelligent workspace.

Protocol & Study Management
Site & Investigator Intelligence
Risk-Based Monitoring Dashboard
Enrollment & Visit Tracking
Regulatory Milestone Oversight
AI Operational Copilot

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◈ eTMF Intelligence Engine

Autonomous Document Intelligence for Trial Master Files

AI-powered document classification, automated filing, and real-time inspection readiness monitoring built on ICH E6(R3) and the DIA TMF Reference Model — so your TMF is always complete, current, and audit-ready.

Automated Document Classification & Filing
TMF Completeness Monitor
Inspection Readiness Scoring
Document Quality Assessment
Country-Specific Regulatory Requirements
Missing Document Alerts & Workflow

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◎ Clinical Evidence Engine

Cross-Document Integrity for Clinical Submissions

Validates consistency and evidence traceability across your protocol, SAP, CSR, and regulatory submissions — catching discrepancies before they reach regulators and accelerating your submission quality review.

Protocol-to-CSR Consistency Validation
Statistical Output Reconciliation
Evidence Tracing & Citation Mapping
Cross-Document Discrepancy Detection
Medical Writing Acceleration
Regulatory Response Support

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Why Aurelyn AI Clinical

Built for the Demands of Regulated Research

Clinical research demands precision, accountability, and compliance at every step. Our platform was designed for that reality from the ground up.

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Regulatory-Grade by Design

GCP, ICH E6(R3), 21 CFR Part 11, and ALCOA+ compliance principles are embedded into every feature — not bolted on after the fact. Audit trails, data integrity, and access controls are built in.

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Clinical-First Intelligence

Built by clinical research professionals who understand the operational realities of trials — not adapted from generic enterprise software. The workflows, terminology, and logic are native to clinical research.

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Purpose-Built AI, Not Repurposed

Our AI models are trained and fine-tuned on clinical research data, regulatory documents, and domain-specific knowledge — not general-purpose LLMs retrofitted to life sciences use cases.

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Integrated Across the Lifecycle

The three engines share a unified data layer — so signals from trial operations, TMF management, and evidence review inform each other, giving you a complete intelligence picture, not siloed outputs.

Built For

Serving the Full Life Sciences Ecosystem

From global pharmaceutical sponsors to emerging biotech, Aurelyn AI Clinical is designed to scale — from a single Phase I study to a global Phase III portfolio.

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Pharmaceutical Sponsors

Portfolio-level oversight, regulatory milestone tracking, and submission quality assurance across complex global programs.

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Contract Research Organizations

Scalable trial management infrastructure that supports multi-sponsor operations with standardized quality and compliance frameworks.

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Biotechnology Companies

Enterprise-grade trial management capability accessible to lean teams — bringing the operational sophistication of large pharma to emerging biotech.

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Academic Medical Centers

Institutional compliance, protocol management, and investigator-initiated trial support aligned with academic research governance requirements.

Clinical Academy

Build Your Team's AI Capabilities

Technology alone doesn't transform clinical research. The Aurelyn AI Clinical Academy provides professional AI training designed specifically for the clinical research workforce.

18+ Courses · 6 Categories · CE Credits Available

From AI Literacy to
Clinical Specialization

Structured learning paths for every role in your clinical research organization — from foundational AI literacy to role-specific training for CRAs, data managers, medical writers, and clinical leadership.

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Introduction to AI

AI Ethics & Governance

AI for Everyday Work

AI Leadership

AI Implementation

AI for Clinical Research