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.
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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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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.
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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.
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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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