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. 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, quality translation an essential priority.
CSOFT Health Sciences’ global network of in-country linguists and clinical trial translation specialists enable clear, cost-effective, and consistent translations for all document types for phase 0-IV of the clinical process and remote clinical trials. From informed consent forms for trial participants to investigator’s brochure (IBs), our subject matter experts ensure the highest possible quality with rapid turnaround through the help of world-class translation tools and processes.
Our Tools and Methodologies
CSOFT Health Sciences brings almost two decades of translation expertise to delivering quality multilingual clinical trial documentation for the life sciences. Perfecting our translation best practices with our cutting-edge cloud-based language technology as well as our linguistic validation process, ensures the highest quality translation for your needs.
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 with accurate and professional medical interpretation services. Professional, high-quality, and accurate medical interpretation is critical in the life sciences to ensure mutual understanding between the patient and healthcare professional, and for enabling 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 interpretation solutions in over 250 languages and our team of professional medical interpreters have experience with both in-person interpretation services as well as remote interpretation, including Over-the-phone interpretation (OPI) and video-remote interpretation (VRI).
Learn more about our clinical trial interpretation services.
Multilingual Clinical Trials
Today, a growing number of clinical trials are conducted globally. From contract research organizations and sponsors to institutional review boards and clinics, CSOFT’s 10,000+ professional medical translators have the linguistic and regulatory expertise and qualifications to help organizations achieve international compliance.
We have experience translating:
Clinical Trial Protocol Translations
Clinical trial protocol translations enable sponsors and CROs to comply with global regulatory standards and communicate the objectives of a clinical trial in different languages. Clinical trial protocols are a crucial document that aims to describe the objective, study design, safety measures, organization, and other important aspects of how the trial will be conducted. For anyone conducting clinical trials overseas and in compliance with global regulatory standards, translations for clinical trial protocols might be required for approval.
Learn more about our clinical trial protocol translations.
Clinical Trial Dossier Translations
Clinical trial dossiers are a crucial collection of documentation that is submitted to EU regulatory bodies to gain authorization for conducting clinical trials. New EU regulations require translations for all types of documents included in the dossier in order to successfully conduct trials in multiple EU countries. For anyone working in the space of clinical trials, ensuring that documents in the dossier such as clinical trial applications (CTAs) and patient questionnaires adhere to EU standards and enable successful patient recruitment and retention are crucial. CSOFT Health Sciences specializes in high quality localization solutions for clinical trial dossiers, with additional expertise in supporting patient engagement with recruitment material translations, COA translations, ICF translations, and more.
Learn more about our clinical trial dossier translations.
Patient Portal Translations
Patient portals are emerging as a leading patient communications and engagement solution in the healthcare and clinical trials sectors. These platforms enable 24-hour access to crucial health information and allow for patients to view and submit important clinical trial documentation, such as questionnaires and recruitment material. In order to reach patients on a global scale and effectively communicate with patients from a diverse background, accurate translations for patient portals are imperative. CSOFT Health Sciences’ global network of linguists and subject matter experts have experience with high quality translations of patient-facing materials and digital health platforms. In support of
conducting international clinical trials and to uphold patient retention and recruitment, our patient portal translations enable companies to reach new markets and populations.
Learn more about our patient portal translations.
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.
Learn more about our quality assurance process.
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.