eArchive

Trial Interactive's eArchive is a purpose-built clinical data management solution designed to provide secure, compliant, and long-term storage for electronic Trial Master Files (eTMFs). Developed by TransPerfect, it serves life sciences companies that need to meet rigorous regulatory requirements, maintain audit readiness, and preserve clinical trial documents over extended retention periods of up to 25 or more years. eArchive acts as the ultimate method of eTMF audit preparation and retention, mitigating the risk of data loss, maintaining data integrity, and enabling efficient document retrieval whenever needed.

By offering a seamless and compliant archiving environment, eArchive allows clinical operations teams to focus on bringing products to market quickly and safely, rather than managing the complexities of long-term document storage and regulatory compliance.

Core Archiving Capabilities

• Regulatory Compliance: Documents are stored in accordance with 21 CFR Part 11 and ISO 27001 standards, ensuring compliance for the full regulatory retention period of 25 or more years.
• Long-Term TMF Storage: Clinical trial documents are preserved in dependable, future-proof formats such as PDF/A and flat files within a long-term active archiving system that meets all applicable regulatory requirements.
• Automated Document Retention: Retention management is fully automated, ensuring documents are preserved for the necessary duration while maintaining integrity and readiness for audits without manual intervention.
• Integrated eTMF Compatibility: eArchive seamlessly archives documents from Trial Interactive eTMFs as well as third-party eTMF systems, ensuring metadata retention and efficient document retrieval across platforms.
• Annual Integrity Checks: Annual checksum verifications and backup recovery reports are conducted to confirm data integrity. Audit trails are reviewed yearly to ensure all files remain intact and easily retrievable in their original form.

Access, Inspection Readiness, and Security

• Secure access is provided for regulatory inspectors, with controls in place to prevent broken filing structures and ensure smooth, controlled document retrieval.
• A comprehensive audit trail is maintained throughout the archiving lifecycle, supporting inspection readiness at all times.
• Document management is simplified through automated retention processes, ensuring clinical data security and straightforward retrieval when required.

Key Benefits for Life Sciences Organizations

• Efficiency and Security: Automated processes reduce manual workload and simplify document management while maintaining the highest standards of clinical data security.
• Audit Readiness: Inspection-ready archives with full audit histories enable smooth and controlled access during regulatory reviews, reducing the risk of inspection findings.
• Global Support: Multilingual document submissions are supported, ensuring compliance across global regulatory systems for international clinical programs.
• Risk Mitigation: Thorough documentation and complete audit histories eliminate compliance risks and demonstrate data integrity and control to regulators.
• Increased ROI: Automated workflows reduce operational costs, improve efficiency, and contribute to quicker regulatory approvals and better overall performance.

eArchive is deployed as part of the Trial Interactive platform by TransPerfect Life Sciences, offering a world-class clinical study data management solution across the full retention lifespan. It is tailored to help life sciences companies navigate the complex regulatory landscape with ease, supporting both Trial Interactive eTMF users and organizations migrating from third-party systems.