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Ethris relies on Trial Interactive TMF Services for document QC, a Clinical Document Lead and a TMF Study Owner on its current trial. Meanwhile, it keeps full ownership of its records in its own sponsor-owned eTMF, getting expert support now and a foundation ready for multi-site expansion.
A large biopharmaceutical company in the middle of a pivotal phase III study, run by seven CROs and vendors, needed help with over 150,000 paper documents across their 450 global investigative sites. They turned to TransPerfect trial master file services for scanning, coding, and TMF inspection readiness expertise to help process their TMF documentation.
85% of studies are delayed, and inspection findings are often a factor. Calculate your TMF Inspection Risk Score®—and know how to improve it — in less than 10 minutes.
Maintain global regulatory compliance.
Work with TMF experts who have FDA, EMA, PMDA and MHRA inspection experience on SOP and process development, TMF Reference Model implementation, TMF best practice and inspection readiness workshops.
Ensure TMF completeness and data quality.
Avoid potential issues with your studies through TMF guidance on quality reviews and TMF health checks that proactively identify and correct documentation and indexing issues.
Simplify TMF document management.
Work with experts for TMF document scanning, naming, indexing, TMF migrations, eTMF archiving and more.
Access the first and only accredited TMF University.
Certify your managers, leaders, and specialists in best practices with the only accredited TMF University in the world.
