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electronic Trial Master File (eTMF)
GAJA eTMF(Globally Accessible e-TMF with Justified Accuracy) is a digital system that manages, stores, and tracks essential documents required for clinical trials. It replaces paper-based filing with a secure, centralized, and compliant electronic repository, ensuring regulatory readiness and streamlined collaboration across all stakeholders.
Why Choose GAJA eTMF for Your Clinical Trials?
- ✔ Regulatory Ready Compliant with ICH-GCP, 21 CFR Part 11, and GDPR standards.
- ✔ Always Audit-Ready Ensures inspectors have real-time access to complete and organized documents.
- ✔ Faster Workflows Automated indexing, versioning, and document workflows save time.
- ✔ Collaboration-Friendly Sponsors, CROs, and sites work seamlessly in a centralized platform.
- ✔ Scalable & Flexible Adapts to single-site studies or global multi-country trials with ease.
Features Of GAJA eTMF
- Centralized Repository Single source of truth for all essential trial documents.
- Advanced Search & Indexing Quickly locate documents with metadata tagging and filters.
- Version Control Tracks revisions, approvals, and maintains audit history.
- Automated Workflows Streamlines submission, review, and approval processes.
- Collaboration Tools Enables sponsors, CROs, and sites to work together seamlessly.
- Secure Access Role-based permissions and encryption safeguard trial data.
Benefits of GAJA eTMF
Centralized Access
Provides a single, secure repository for all trial documents, accessible anytime.
Regulatory Readiness
Ensures compliance with 21 CFR Part 11, ICH-GCP, and global regulatory standards.
Enhanced Collaboration
Enables sponsors, CROs, and sites to work together with real-time visibility.
Improved Efficiency
Speeds up document submission, review, and approvals with automation.