A Trial Master File, or TMF, is a collection of documentation submitted to regulatory agencies to enable monitoring and assessing a clinical study’s adherence to Good Clinical Practice (GCP) principles and approved protocol. TMFs are crucial for conducting clinical trials because they protect patient data and confidentiality, allow for a study to be recreated in an unbiased manner, and allow regulatory agencies to have a deeper understanding of how the study was conducted. Trial Master Files can come in both hard copy versions as well as electronic versions known as eTMFs. Given their importance, Trial Master File translations must be done both accurately and quickly .
As the number of clinical trials conducted in regions where English is not the primary language grows, critical clinical trial documents such as TMFs and eTMFs need to be translated into the local language and include all relevant documents required by each regulatory agency to ensure compliance and maintain market access. Failure to do so can cause delays in regulatory approval, increasing the time to market for medical devices or pharmaceutical products, leading to losses in revenue and time for clinical trial sponsors. CSOFT’s global network of 10,000+ in-country native linguists and subject matter experts (SMEs) provide investigators, CROs, and clinical trial sponsors with highly-accurate and timely TMF and eTMF translations in over 250 languages.
Essential Document Translation
The Essential Documents are a major component of a TMF or eTMF. Although the Essential Documents required by each regulatory agency can varies, Essential Documents can include clinical trial protocols, investigator brochures, eCRFs, storage and shipment records, contracts, documents for Ethics Committees, and more. CSOFT’s global network of 10,000 in-country native linguists and SMEs can provide you with rapid and accurate Essential Document translations to give clinical trial sponsors and CROs the best ROI and maintain regulatory compliance.
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High-quality translation is extremely important for medical trials – inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. That is why CSOFT is dedicated to ensuring the highest-quality translation for life science companies, researchers and CROs conducting clinical trials worldwide. In order to do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts. In addition, we have perfected our translation localization best practices through linguistic validation, back translation, back translation, in-country review (ICR) and terminology management, we have the tools and team to help you reach patients globally.
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We have well-documented and fully traceable information security policies, checklists, and quality records. CSOFT understands the importance of security to our clients and we take nothing for granted when confidentiality is a concern. All our data and security processes comply with our certified ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001.
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