Trial Master File (TMF) Translation Services
Providing life science companies, researchers, and CROs with high-quality trial master file translations in 250+ languages
A Trial Master File (TMF) is a collection of documentation that is submitted to regulatory agencies to enable monitoring and assessment of a clinical study’s adherence to Good Clinical Practice (GCP) principles and approved protocol. This fact makes TMF translations essential for global studies. TMFs are crucial for conducting clinical trials because they protect patient data and confidentiality, allowing a study to be replicated unbiasedly, and allowing regulatory agencies to have a deeper understanding of how the study was conducted. Trial Master Files can come in hard copy and electronic versions known as ETFs. Given their importance for regulatory approval in markets with multiple language requirements, TMF translations must be done accurately and quickly to ensure swift approval of required documentation.
As the number of clinical trials grow in regions where English is not the primary language , critical documents, including TMFs and eTMFs, need to be translated into the local language, including 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, extend the time to market medical devices or pharmaceutical products, and lead to revenue loss for clinical trial sponsors.
CSOFT Health Sciences’ global network of 10,000+ in-country native linguists and subject matter experts (SMEs) provides investigators, CROs, and clinical trial sponsors with highly accurate and timely TMF and eTMF translations in over 250 languages. We offer comprehensive translation and localization solutions for documents included in TMFs, including:
- Clinical Trial Protocol
- Investigator’s Brochure (IB)
- Patient Information Document
- Medical SOP
- Case Report Form (CRF)
- Drug Product Labeling
- Procedural Manual
- Statistical Analysis Plan
Essential Document Translation Services
Essential Documents are a significant component of TMFs or eTMFs. Although the essential documents required by each regulatory agency can vary, they often 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 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 Translation Services
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 trial translation solutions necessary when conducting clinical trials overseas. Clinical trial translations are crucial for pharmaceutical companies expanding in overseas markets to meet local regulatory requirements. With that said, inaccurate translation risks regulatory viability in the target market and 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 enables clear, cost-effective, and consistent translations.
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Quality Assurance
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 seven 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 real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.
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Data Security
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. They 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.
Learn more about how CSOFT prioritizes data security.