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Endpoint Adjudication Translations

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

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Who needs endpoint adjudication translations, and why do they matter? 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. Thus, as more and more clinical trials are conducted in countries where English is not the primary language, sponsors and CROs need highly accurate translations of both endpoint adjudication and source case documents with fast turnaround times needed 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.

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.

High Quality Academic 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.

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