eTMF

Octalsoft eTMF is a cloud-based Electronic Trial Master File system designed for sponsors, CROs, and site teams involved in clinical trials. It centralises trial documentation, applies AI-driven quality checks, and provides real-time oversight to support continuous inspection readiness. The system is pre-mapped to the DIA eTMF Reference Model and is built to support Phase I–IV and global, multi-site studies.

The platform incorporates AI for document categorisation, completeness monitoring, version control, and predictive compliance analytics. It is designed to meet regulatory requirements including 21 CFR Part 11, ICH-GCP, HIPAA, and GDPR.

Centralized Trial Documentation

• Cloud-based repository for all trial master file documents.
• AI-powered categorisation and indexing for fast, reliable retrieval.
• Pre-mapped to the DIA eTMF Reference Model for standardisation.
• Scales across Phase I–IV and global, multi-site studies.

AI-Driven Quality and Completeness Checks

• Automated quality control to meet regulatory and protocol standards.
• AI flags missing, incomplete, or duplicate records.
• Risk-based scoring identifies compliance gaps to support faster remediation.
• Supports continuous audit and inspection readiness.

Version Control and Audit Trail

• Secure version management with controlled access.
• AI detects unauthorised edits and inconsistencies.
• Comprehensive audit trail captures every change, approval, and e-signature.
• Compliant with 21 CFR Part 11, ICH-GCP, HIPAA, and GDPR.

Collaboration Across Stakeholders

• Role-based access supports secure sponsor–CRO–site collaboration.
• Automated workflows streamline document review and approval cycles.
• Real-time notifications keep trial teams aligned.
• Reduces bottlenecks in submissions and monitoring activities.

Real-Time Oversight and Analytics

• Custom dashboards track trial progress and TMF health metrics.
• AI-driven analytics identify compliance risks proactively.
• Automated reporting supports decision-making and submissions.
• Provides transparent oversight for both sponsors and CROs.

Role-Specific Benefits

• Sponsors: Real-time visibility and centralised document oversight to maintain global compliance and continuous inspection readiness across all studies.
• CROs: Standardised documentation processes across multiple sponsors, with the ability to scale while reducing administrative workload and compliance risks.
• Site Teams: Simplified document management aligned with sponsor requirements, reducing manual effort while maintaining audit-ready documentation.

Add-ons and Integrations

• Octalsoft eDocs integrates with the TMF to synchronise trial documents for streamlined oversight.
• Octalsoft CTMS connects TMF compliance with trial milestones and operational data.
• Native integration with eDocs, CTMS, eConsent, rSDV, and EDC within the Octalsoft eClinical Suite.

Octalsoft eTMF is part of a broader eClinical platform that covers the full trial lifecycle. The company offers personalised onboarding, 24/7 support, and ongoing optimisation services. All systems are designed to meet global regulatory standards including 21 CFR Part 11, GCP, and GDPR.