Clinical Trial Application Translations for Multilingual Clinical Trials
The clinical trial application is a crucial component of European clinical trials, making clinical trial application translations essential for regulatory compliance across languages. A clinical trial application (CTA), or CTA dossier, is submitted to European regulatory agencies to ensure that the investigational medicinal product (IMP) or other medical product being tested is approved for use in a clinical trial. CTAs comprise a wide range of translated documents that vary by clinical trial, but may include:
CSOFT Health Sciences’ global team of subject matter expert linguists have a minimum of 7 years in-country experience to ensure that your clinical trial application translations are accurate and follow regulatory guidelines. Perfecting our translation best practices with our cutting-edge cloud-based language technology as well as our linguistic validation process, ensures the highest quality medical translation for all your clinical trial needs.
End-to-End Clinical Trials Translations
As more and more clinical trials incorporate innovative technology and focus on patient-centric care, the need for multilingual trial documents is essential for communications and international regulatory compliance in Europe and beyond. Whether you are a pharmaceutical company, medical device manufacturer, or involved in other medical product clinical trials, bringing new products to market necessitates translations for a broad range of clinical trial documents, in addition to ensuring the highest degree of accuracy by using localization solutions like linguistic validation. To help trial stakeholders meet international regulations for clinical trials, CSOFT Heath Sciences offers a full range of medical translations in 250+ languages.
Learn more about our full coverage of clinical trial translations.
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.
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.
Learn more about our quality assurance process.
