Endpoint Adjudication Translations

Providing life science companies with accurate and timely endpoint adjudication translation solutions to ensure clinical trial safety

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In endpoint adjudication, a blind committee of experts – known as Clinical Event Committees (CEC) or Endpoint Adjudication Committees – independently evaluate clinical events from a clinical trial and adjudicates them with predetermined event classification criteria, reducing potential bias and increasing the validity of trial outcomes. As more and more clinical trials are conducted in countries where English is not the primary language, the need for highly accurate translations of both endpoint adjudication and source case documents with fast turnaround times are vital for successful clinical trials. With a global network of 10,000 in-country linguists and subject-matter experts (SMEs), CSOFT provides high-quality endpoint adjudication translation solutions for life science companies conducting clinical trials in more than 250 languages, from adjudication documentation translation to endpoint adjudication software translation and localization.
Endpoint adjudication translations

Endpoint Adjudication Documentation Translation

Endpoint adjudication documentation must be submitted to regulatory agencies such as the United States’ FDA and the European Union’s EMA in order to receive marketing authorization. Because such documents are important for reviewing and classifying potential safety events, rapid submission and highly-accurate translations of endpoint adjudication submission package documents such as endpoint adjudication charters, adjudication forms, and adjudication manuals is vital. CSOFT’s international network of 10,000 linguists and subject matter experts provides high-quality and accurate translations of endpoint adjudication documentation with quick turnaround times in over 250 languages, from training materials for adjudication members and adjudication results outputs to internal and external progress reports and meeting minutes.

Learn more about our medical document translation services.

Software Translation and Localization

Endpoint adjudication software has emerged as a way to simplify the endpoint adjudication process. As the number of clinical trials held in countries where English is not the primary language increases, it is increasingly important for endpoint adjudication software manufacturers to deliver highly-accurate and properly translated and localized adjudication software to successfully compete in foreign markets. From UX/UI localization and linguistic testing to functional and cosmetic testing, CSOFT provides end-to-end software translation and localization solutions to help endpoint adjudication software companies meet regulatory demands and access new markets.

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Quality Assurance

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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High Quality Academic Translations
ISO-certified Academic Translations

Data Security

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.

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Data Security

We have well-documented and fully traceable information security policies, checklists, and quality records. CSOFT understands the importance of security to our clients and we take nothing for granted when confidentiality is a concern. All our data and security processes comply with our certified ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001. 

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