A Trial Master File (TMF) is a collection of documentation submitted to regulatory agencies to enable monitoring and assessment of a clinical study’s adherence to Good Clinical Practice (GCP) principles and approved protocol, which makes Trial Master File translations essential for global studies. TMFs are crucial for conducting clinical trials because they protect patient data and confidentiality, allow for a study to be replicated 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 for regulatory approval in markets with multiple language requirements, Trial Master File translations must be done both accurately and quickly to ensure swift approval of required documentation.
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 and leading to losses in revenue and time for clinical trial sponsors. CSOFT Health Sciences’ 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. We offer comprehensive localization solutions for documents included in TMFs, including:
Essential Document Translations
The Essential Documents are a major component of a TMF or eTMF. Although the Essential Documents required by each regulatory agency can vary, Essential Documents can include clinical trial protocols, investigator’s brochures, eCRFs, storage and shipment records, contracts, documents for Ethics Committees, and more. CSOFT Health Sciences’ 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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Clinical Trial Translations
Clinical trials account for an enormous portion of the investment required to bring drug therapies, medical devices, and innovative treatments to market in any country, making clinical trials translation solutions necessary when conducting trials overseas. For pharmaceutical companies expanding in overseas markets, clinical trial translation is crucial to meet local regulatory requirements. However, inaccurate translation risks regulatory viability in the target market, as well as potentially endangers patient safety and drug efficacy, making precise, high-quality translation an essential priority for all stakeholders involved. CSOFT Health Sciences’ global network of in-country linguists and clinical trial translation specialists enable clear, cost-effective, and consistent translations.
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CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have at least 7 years of experience and work with in-country reviewers and project style guides to meet industry standards. CSOFT offers an online translation management ecosystem for one central location to leverage translation memory and terminology management in real time through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.
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With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage the best practices of ISO 27001 and are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.
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