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Dossier Translations

CSOFT Health Sciences provides professional dossier translations in 250+ languages to ensure that all clinical trial documentation is in accordance with regulatory standards.

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Dossier Translations for Multilingual Clinical Trials

Dossier translations help pharmaceuticals and medical device companies, CROs, and academic institutions ensure that new health products gain regulatory certification in time for approval before market, in all the languages required for a specific regulatory environment. A clinical trial dossier translation 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 translation 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 translation for all types of documents required in the dossier, in addition to a full range of medical translation and 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 to the dossier need to be accurate, consistent, and completed efficiently, often within a short period of time. Dossiers contain crucial information including protected health information (PHI) and clinical data that requires expert attention to detail and industry knowledge when it comes to medical 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 clinical outcome assessment translations to patient recruitment translations. Additionally, CSOFT specializes in end-to-end translations, from helping companies in need of quality dossier translations all the way to instructions for use (IFU) translations, and more.

Learn more about our medical document translation services.

End-to-End Translations for Clinical Trials

With the global rise of industry clinical trials, reaching patients and communicating with 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, MedTech or health tech, 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 is IRB correspondence translationsphase 0-IV clinical trial translations, or medicomarketing translations, CSOFT Health Sciences specializes in supporting companies with end-to-end medical translation and localization solutions for all steps of the clinical trial process.

With a global network of 10,000+ linguists and medical subject matter experts, we provide cost-effective and timely translations for all types of clinical trial documents, including:

Learn more about our clinical trial translations.

Clinical Trial Interpretation Services

With an increasing number of clinical trials being conducted overseas, it’s important that patients with Limited English Proficiency (LEP) and multilingual backgrounds are provided accurate and professional clinical trial and medical 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 and their families 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 options, including over the phone interpreting (OPI) and video remote interpreting (VRI).

Learn more about our clinical trial and medical interpretation services.

CRO-Focused Translation Solutions

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 reaching new populations of patients across languages, 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.

Learn more about our CRO translations.

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 endpoints and objectives, the study design, patient and drug safety measures, and more. High-quality translation 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 translationsInvestigator’s Brochure (IB) translationsinformed consent form (ICF) translations, and more.

Learn more about our clinical trial protocol translations.

Quality Assurance

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.

Professional, high-quality localization of a health service or medical product is critical for medical translation solutions entering global markets. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance to ensure that any project that is translated meets quality standards in a timely manner that is also cost effective. Our advanced translation technology management system allows for translation projects to remain in one centralized location, updated in real time, to ensure that every step of the way, CSOFT has you covered. Additionally, we are certified in  ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, and our operations leverage best practices of ISO 27001 to ensure our customized solutions meet global regulatory requirements.

Learn more about our quality assurance process.

High Quality Academic Translations
ISO-certified Academic Translations

Data Security

As an ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified company, with operations leveraging best practices of ISO 27001, CSOFT’s translation process includes in-country reviewers, utilizing either new or established style guides, and subject matter expert (SME) linguists with a minimum of 7 years of experience. With over 20 years of industry experience, we have developed mature processes for translation, editing, proofreading (TEP), as well as project management.

Learn more about how CSOFT protects companies’ data.

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