From patient information sheets and medico-marketing materials to clinical service agreements and common technical documents (CTDs), medical document translation services are essential for a variety of document types found across the life science and healthcare industries. The life science sector is a knowledge industry and relies heavily on acronyms and technical terminology. Thus, for life science companies expanding overseas, accurate medical document translations are crucial in gaining market access and complying with local regulatory requirements.
Whether you are a medical device manufacturer, pharmaceutical retailer, medical distributor, or involved in biomedical engineering, CSOFT Health Sciences has the experience and resources to ensure highly accurate translation solutions for all types of medical documents.
Industries We Serve
CSOFT Health Sciences specializes in end-to-end translation for all stages of the product development lifecycle, with high-volume document translation solutions for a variety of medical and healthcare document types including:
Efficiently Meeting the Highest Standards Through Terminology Management
Effective terminology management is essential not only to ensuring the quality and consistency of each document, but also to expediting urgent translation needs with rapid turnaround times and reduced costs. In fact, implementing effective terminology management at the outset of a translation project can save 20% or more in total costs and reduce errors by 50%.
For companies in the life sciences industry, terminology management is even more important to ensuring documents are in strict compliance with the highest regulatory standards, as well as ensuring the safety of end users and patients.
CSOFT Health Sciences’ cloud-based terminology management system (TMS), AI-powered translation memory system, and glossary management practices ensure that every document in a series is translated consistently and to the specifications for target markets, with in-country linguists helping to ensure the most up-to-date terminology across target geographic regions.
Learn more about our terminology management services.
Multilingual Desktop Publishing (DTP) for Medical Document Translation
Desktop publishing, also known as DTP, occurs at the end of the medical translation or localization process, and involves redesigning and formatting a document’s graphic design, typesetting, and formatting columns, graphs, and tables according to international typographical rules and industry standard practices using page layout software. As the demand for healthcare products continues to grow overseas, accurately translated and properly formatted medical documents is crucial for market access and product success.
CSOFT Health Sciences’ desktop publishing specialists have experience working with all industry-standard desktop publishing and graphic tools, as well as diverse document formats, to support DTP on Windows, Linux, and Mac platforms.
Learn more about our multilingual DTP services for medical documents.
Certified Translation Services for All Medical Document Translation
CSOFT Health Sciences’ translation best practices include the use of in-country reviewers and subject matter experts specific to each project we undertake, with linguists holding a minimum of 7 years of in-field experience. Each technical document that we deliver undergoes thorough translation, editing, and proofreading (TEP), with linguistic validation and additional services as required to meet the rigorous requirements or regulatory submissions, patient information, and medical product documentation.
Learn more about our certified translations.
Advanced Technology for Content Management and Product Success
For life science companies expanding overseas, large volumes of medical documents require advanced language technology for continuous, high-quality translation. Leveraging a content management system (CMS) enables content reuse for quality, consistency, reduced time-to-market, and in the case of localization, a significant reduction in translation costs. Our other AI technology tools, like machine translation (MT) as well as translation memory (TM), help manage continuous, high-quality translation for large projects without sacrificing money or time.
Learn more about our advanced language technology for medical document translation.
Adhering to Regulatory Standards for CTD and eCTD Submissions with Optimized Formatting
Regulatory bodies enforce rigid specifications for CTD and eCTD submissions, which include strict language and translation guidelines. Pharmaceutical organizations risk significant delays in market entry and consequential revenue shortfalls if the formatting of these documents does not meet the stipulated standards. CSOFT Health Sciences employs a proficient team of desktop publishing (DTP) engineers who provide formatting assistance in compliance with these regulations, ensuring prompt submissions. This efficient service guarantees the most beneficial return on investment for pharmaceutical firms.
Learn more about our CTD and eCTD translations.
Patient Information Sheet Translations
As clinical studies continue to grow worldwide, patient information sheet translations are necessary to exchange patient information and utilize patient-centric data in future research studies. Communication between patients and providers is essential in healthcare treatment and inaccurate translations can have consequences such as false information being exchanged, or confidential information being shared without the consent of the patient. Whether you are a healthcare provider, patient, or clinical research organization, patient information sheets need to be in regulatory compliance to ensure patient data privacy. With a global team of 10,000+ in-country linguists and subject matter experts, CSOFT Health Sciences provides high-quality customized medical translation and localization solutions for patient information sheets. From clinical studies to patient-provider interactions, CSOFT’s translation and interpreting support in over 250 languages enables growing healthcare and research organizations to deliver patient information sheet solutions across language barriers.
Learn more about our patient information sheet translations.
Good Documentation Practices (GDP) Translations
Good Documentation Practices (GDP), also referred to as GDocP, describes a set of standards that are designed for the pharmaceutical and medical device industries and required by most regulatory bodies including the FDA, EMA, NMPA, TGA, and more. These procedures are typically carried out electronically, and mandates for life science companies to keep a variety of documented records throughout the product’s lifecycle. CSOFT Health Sciences understands that high quality medical translation of these documents is essential for international regulatory compliance, for every medical document.
Learn more about our good documentation practices (GDP) translations.
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 a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time. Every step of the way, CSOFT has you covered.
Learn more about our quality assurance process.
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 best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.