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Maintained by TransPerfect Service Personnel and your Archivist
Capability to store documents from Trial Interactive eTMFs or from a third-party eTMF
Automated document retention management
Streamlined document retention management
Long-term accessible in dependable formats including PDF/A and Flat Files
Available to Regulatory Inspectors as needed
Maintained in long-term cold storage to meet EMA requirements
Inspection-Ready at all points with audit trail reporting
Available to admin staff and Archivist role
Integrity and checksum verification with annual backup and recovery reports
Discover the power of our dynamic active room – strategically designed to supercharge your study closure process. Seamlessly access vital documents for inspections and audits, ensuring compliance and efficiency. Experience unrivaled convenience, especially within the critical first 2 years post-trial completion.
Experience the ultimate peace of mind with our archived study feature. Safeguard your documents during critical moments, staying inspection ready and ensuring oversight over all documents and data. Access controls are of the utmost importance in this active archive - particularly when needing to retrieve information on a recently closed study. Your document integrity remains intact, particularly during circumstances when precision matters most.
Elevate your document management strategy with our cold storage as PDF/A and flat files solution. Immerse your documents, metadata, and folder structures in an archived environment. With a focus on integrity, ensure your data remains audit-ready for over 25 years post-trial completion.