AI-powered document classification, automated filing, and real-time inspection readiness monitoring built on ICH E6(R3) and the DIA TMF Reference Model. Your TMF is always complete, current, and audit-ready.
Platform Overview
The Trial Master File is the bedrock of every clinical trial — and one of the most operationally demanding components of regulatory compliance. Manual TMF management is slow, error-prone, and increasingly unsustainable as trial complexity grows. Documents are misfiled, completeness monitoring lags behind the trial, and inspection readiness is assessed only when it's almost too late.
The Aurelyn AI eTMF Intelligence Engine changes the equation. It automates the most time-consuming elements of TMF management — document classification, filing against the DIA Reference Model, completeness monitoring, and quality assessment — freeing TMF teams to focus on governance and strategic compliance oversight rather than administrative burden.
Built on ICH E6(R3) and the DIA TMF Reference Model, with full 21 CFR Part 11 audit trail capability, the eTMF Intelligence Engine is designed for the inspection-facing reality of clinical document management.
The eTMF Intelligence Engine receives trial status and milestone data from the Clinical Trial OS — enabling automated document expectations based on where your study is in its lifecycle. Document completion insights also feed the Clinical Evidence Engine's submission quality layer.
Core Capabilities
Eight AI-powered capabilities that cover the full TMF management lifecycle — from the moment a document is created to the day an inspector arrives.
How It Works
The eTMF Intelligence Engine handles the complete document lifecycle — from the moment a file enters the system to the day an inspector requests access.
Documents enter the system via direct upload, email integration, site portal submission, or API connection with your existing eTMF or document management system. The engine accepts all standard clinical document formats.
The document AI reads content, identifies the document type and scope, and files it into the correct DIA TMF Reference Model position — zone, section, and artifact. Classification confidence scores are displayed, with human review queues for low-confidence items.
Each document is quality-assessed against ALCOA+ principles and document-type-specific requirements. Simultaneously, the completeness monitor updates the TMF's expected-vs-received status against study milestones and site activations — surfacing gaps in real time.
The inspection readiness score is continuously updated. Inspection simulation mode lets you model what an FDA, EMA, or MHRA inspection would find — identifying remaining gaps before an inspector does. When inspection begins, controlled access is granted with full audit trail.
Regulatory Framework Alignment
The eTMF Intelligence Engine's logic, document expectations, and quality criteria are grounded in the regulatory frameworks your TMF will be measured against.
Inspection Readiness
Real-time inspection readiness is the ultimate goal of TMF management. The eTMF Intelligence Engine maintains a continuous readiness score with granular visibility into every gap.
Illustrative Inspection Readiness Dashboard
Model what an FDA, EMA, or MHRA inspection would find — generating a prioritized gap list with remediation timelines and responsible party assignments.
Move from reactive TMF remediation before an inspection to proactive, continuous compliance maintained throughout the trial lifecycle.
Built For
Ecosystem
The eTMF Intelligence Engine integrates with your existing eTMF platform, document management systems, and the broader Aurelyn AI Clinical platform — without requiring replacement of your current infrastructure.
See how the eTMF Intelligence Engine transforms TMF management from a reactive burden to a proactive compliance advantage.