Inductive eTMF

Metadata-Driven Trial Master File Management for Modern Clinical Studies.

From Day-One Study Setup to Continuous Inspection Readiness

Inductive eTMF is designed to modernize how trial master files are built, maintained, and kept inspection-ready. Through a metadata-driven taxonomy aligned to the DIA TMF Reference Model, automated Expected Document List generation, milestone-driven due dates, and AI-enabled document classification and metadata extraction, the platform helps teams reduce manual filing effort while improving completeness and control.

With standards-aligned workflows and support for 21 CFR Part 11 controlled approvals and one-click inspection-ready archival with minimal manual intervention, Inductive eTMF helps sponsors and CROs surface document gaps earlier, reduce last-minute remediation, and reach inspection readiness with greater confidence.

Core Features

Built to accelerate TMF setup, improve document completeness, and shorten the path to inspection readiness.

Configure studies through a structured, metadata-driven TMF foundation that improves consistency, supports reuse, and accelerates setup across studies, countries, and sites.

Metadata-Driven TMF Taxonomy

Model the trial master file dynamically on the DIA TMF Reference Model with versioned, reusable taxonomies to reduce manual setup, improve standardization, and support faster study deployment.

Automated Expected Document List (EDL)

Generate the expected document list automatically from artifacts, milestones, and due rules to surface gaps early, enforce completeness, and reduce last-minute remediation.

AI-Enabled Classification & Metadata Extraction

Apply AI to classify incoming documents and extract metadata to file content faster, reduce manual data entry, and strengthen confidence in intake and review workflows.

QC Review & Query Management

Manage quality reviews, deficiency tracking, and document queries through streamlined workflows that support faster resolution, better collaboration, and improved study control.

Controlled Approvals & Electronic Signatures

Govern final sign-off with 21 CFR Part 11 electronic signatures and a controlled document lifecycle to ensure authenticity, accountability, and regulatory defensibility.

Role-Based Workflow Control

Support secure, role-specific access and governed workflows across study teams, helping ensure control, accountability, and traceability.

External Collaboration & Integration Readiness

Enable secure document requests, partner submissions, and alignment with CTMS, EDC, IRT, and IRB systems to support more connected and complete trial documentation.

Operational Dashboards & Study Oversight

Provide real-time visibility into completeness, missing and overdue documents, QC status, and study risk to support informed decisions and proactive oversight.

Inspection-Ready Archive Generation

Support dynamic generation of inspection-ready TMF archives complete with audit trail and structure metadata with minimal manual intervention to accelerate regulatory readiness.

Faster Inspection Readiness Enablement

Reduce filing backlogs, improve issue resolution, and support cleaner document workflows that help teams reach inspection readiness with greater confidence.

Study Types We Support

Inductive eTMF is designed to support a broad range of clinical and research study models through a flexible, metadata-driven trial master file platform.

Clinical Trials

Manage the complete trial master file for Phase I–IV and other interventional studies with structured taxonomies, expected-document tracking, and controlled review and approval workflows.

Medical Device Studies

Enable flexible TMF setup and compliant document management for device investigations and performance studies.

Real-World Studies

Organize, file, and maintain documentation for non-interventional, observational, and routine-care research programs.

Epidemiology Studies

Support structured TMF management for longitudinal, cross-sectional, and population-based studies across diverse research settings.

Academic & Investigator-Initiated Studies

Provide configurable TMF structures and workflows for academic institutions, research networks, and investigator-led programs.

Post-Marketing & Registry Studies

Support post-approval documentation, registries, and long-term follow-up studies with scalable oversight and retention controls.

Hybrid & Decentralized Studies

Support modern study models with flexible workflows for distributed document collection, external collaboration, and remote site participation.

Ready to Modernize Your Trial Master File?

See how Inductive eTMF can help you improve document quality, reduce filing effort, and achieve continuous inspection readiness with a personalized demo.