CSOFT Health Sciences provides professional dossier translations in 250+ languages to ensure that all clinical trial documentation is in accordance with EU regulatory standards
A clinical trial dossier is an important collection of documents that is presented before a US or EU Regulatory Agency to gain authorization for a new medical device or drug therapy. The dossier itself contains a number of necessary documents, such as clinical trial application (CTA) forms, Investigational Medicinal Product Dossiers (IMPD), Summary of Product Characteristics (SmPC), and more. To help our clients reach patients globally, CSOFT Health Sciences provides highly accurate translations for all types of documents required in the dossier, in addition to a full range of localization solutions for remote clinical trials.
Accurate Dossier Translations
Clinical trial dossiers are a requirement under EU and US regulatory standards, meaning that translations for the documents necessary in the dossier need to be highly accurate and completed under tight timeframes. Dossiers contain crucial information including patient health information and clinical data that requires expert attention to detail and industry knowledge when it comes to translations. CSOFT Health Sciences’ network of 10,000+ linguists and experts in clinical trial dossier subject matter provide effective medical communication solutions for documents ranging from patient questionnaire translations to patient recruitment translations, and we specialize in helping companies in need of quality dossier translations.
Learn more about our accurate clinical trial dossier translations.
End-to-End Translations for Clinical Trials
With the global rise of clinical trials, reaching patients and international regulatory authorities across linguistic and cultural barriers requires translations for all types of clinical trial documentation. Beyond ensuring that documents meet specific language requirements, translations also enable those conducting a trial to collect data that more precisely reflects the population being studied and remain consistent with Good Clinical Practice (GCP) guidelines. For anyone working in pharmaceuticals, biotech, medical devices, and healthcare, accurate and high-quality clinical trial translations can further help to streamline the product development cycle and reach new markets quicker. Whether it be clinical research translations, phase 0-IV clinical trial translations, or medico marketing translations, CSOFT Health Sciences specializes in supporting companies with end-to-end localization solutions for all steps of the clinical trial process.
With a global network of 10,000+ linguists and subject matter experts, we provide cost-effective and timely translations for all types of clinical trial documents, including:
Clinical Trial Interpretation Services
With an increasing number of clinical trials being conducted overseas, it’s important that patients of non-English-speaking backgrounds are provided accurate and professional clinical trial interpretation services. Professional, high-quality, and accurate dossier translations are critical for clinical trial interpretations and ensure mutual understanding between the patient and healthcare professionals. This enables patients from diverse backgrounds to make informed decisions in regard to their health, as well as understand the associated risks for participating in a clinical trial.
CSOFT Health Sciences provides expert clinical trial document translations and interpretation solutions across 250+ languages. Our team of professional clinical trial interpreters have experience with both in-person interpretation services, as well as remote including OPI and VRI.
Find out more about our clinical trial interpretation services.
Contract Research Organizations (CROs) provide support throughout the clinical trial process, particularly in areas like management, product development, and pharmacovigilance. CROs must also be fully aware of all documentation, including dossiers, that are associated with the trial. As a growing number of clinical trials are being conducted in international settings and new populations of patients are being reached, quality translations for CROs are a necessity for gaining access to new markets and regulatory requirements. CSOFT Health Sciences supports CROs with cost-effective translations of documents for all stages of clinical trials.
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Clinical Trial Protocol Translations
Clinical trial protocols are written to ensure that the scientific methods and standard operating procedures of a clinical trial can be repeated or assessed by any company or regulatory agency. Protocols for clinical trials also aim to standardize important features of the trial, including the objective, the study design, the safety measures, and more. High-quality translations of clinical trial protocol documentation is essential for any company conducting international trials and reaching linguistically and culturally diverse populations. For all types of documents required in a protocol, CSOFT Health Sciences provides expert localization solutions, including IRB correspondence translations, Investigator’s Brochures (IBs) translations, Informed Consent Form (ICF) translations, and more.
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High-quality translation is extremely important in the life sciences, and inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance specific to the life sciences, which includes linguistic validation, to ensure that any project meets quality standards in a timely and cost effective manner. 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 and advanced language technology. In addition, we have perfected our localization best practices through back translation and terminology management to help you reach patients globally, in over 250 languages. To further ensure the highest-quality technical translation solutions, CSOFT’s proven expertise is backed by our ISO 17100:2015,ISO 9001:2015, and ISO 13485:2016 certified quality management system.
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CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data and security processes are certified with ISO 13485:2016, ISO 9001:2015, and ISO 17100:2015, and leverage best practices from ISO 27001.
Learn more about how CSOFT protects companies’ data.