Clinical Outcome Assessment (COA) Translations
Providing professional, high-quality medical translation and linguistic validation for all types of clinical outcome assessment (COA) translation needs
A clinical outcome assessment (COA) is a tool used to measure a patient’s experience of a clinical trial in relation to their feelings, functionality, or survival, making clinical outcome assessment translations an essential component of clinical trials being conducted with participants across multiple languages. Clinical outcome assessment translations help research organizations provide transparency to regulators, drug developers, and patients about clinical endpoints, and are required by most regulatory bodies including the FDA and EMA. In addition, the information provided in COA translations helps to inform sponsors, physicians, and regulatory bodies of potential ways to improve patient care and make more informed decisions for public health. As more pivotal trials embrace agile trial design and seek to adopt methodologies such as flexible clinical trial design and inclusive clinical trial recruitment, it is important to ensure that COA translations can account for the reporting priorities these criteria introduce, especially when crossing cultural barriers to perform assessments.
A patient-reported outcome is a type of clinical outcome assessment that comes directly from the patient regarding their health
A clinician-reported outcome is an evaluation of a patient’s condition by a trained physician, nurse, or other health professional involved in the clinical trial.
Performance-Reported Outcome (PerfO) Translations
A performance-reported outcome is when the patient’s health is assessed through a task or performance, rather than by an individual or the patient themselves.
Observer-Reported Outcome (ObsRO) Translations
An observer-reported outcome is an evaluation conducted by someone other than the patient or trained physician, typically a family member or someone involved closely in the patient’s life in a non-clinical setting.
Multilingual Clinical Trials
For multilingual clinical trials, accurate COA translations are imperative not only to meeting regulatory compliance, but also for ensuring the voices of patients from diverse backgrounds are heard throughout the inclusive clinical trial process. In addition to translating patient-reported outcomes, clinician-reported outcomes, performance reported outcomes, and observer-reported outcomes, a rigorous linguistic validation process must be performed to ensure quality and validity of the assessment. All COAs must be translated and validated through a clear linguistic validation process by an experienced team of professional linguists, subject matter experts (SMEs), and project managers.
CSOFT Health Sciences works with life science companies involved in the drug development process to ensure the highest-quality COA translation and linguistic validation process for multilingual, flexible clinical trials. Our methodology follows the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) workflow guidelines and recommendations, ensuring harmonization for regulatory bodies, sponsors, patients, and drug developers. With an extensive network of over 10,000 professional in-country linguists and subject matter experts, we have the resources and experience to help pharmaceutical companies and CROs expand globally.
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Ensuring Patient-Centered Clinical Trials Through Linguistic Validation
Linguistic validation is critical in maintaining the quality and credibility of clinical outcome assessments (COAs) in multilingual and international clinical trials. With clinical trials expanding across diverse nations and languages to enhance participant diversity and broaden product portfolios, accurate medical translations become a regulatory necessity, especially for patient-focused trials that rely on COAs. The process of linguistic validation, handled by professional life science linguists and subject matter experts, involves comprehensive translation steps such as medical terminology management, forward and back translation, linguistic harmonization, and language reconciliation. These steps ensure standardized patient-reported outcomes and other patient-related documents across study sites for accurate data collection, thus expediting market entry for companies.
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Case Report Form (CRF) Translations
During a clinical trial, case report forms (CRFs) are a crucial document used by trial sponsors to collect patient data for hypothesis testing and data analysis. Within a CRF, data including a patient’s height, weight, pulse, blood pressure, temperature, and potential adverse events are documented and used to assess the efficacy of the device or medication being tested in the trial. With an increasing number of clinical trials being conducted across multiple languages, CRF translations are necessary for regulatory compliance and ensuring that the patient data is accurately recorded. To help CROs and sponsors uphold the validity of their data and remain in compliance with regulations for conducting clinical trials, CSOFT Health Sciences offers high quality and timely CRF translations.
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Patient Diaries Translations
Patient diaries function as an essential questionnaire document that is used during pivotal clinical trials to document patient-reported outcomes (PROs). Within a patient diary, the study subject is typically tasked with documenting information, such as potential adverse events, symptoms, and the specific times when medication was taken. As an important clinical outcome assessment (COA) tool, patient diaries need to be available in the native language of the patient and be translated into the language as required by clinical trial regulation. To help sponsors and CROs successfully conduct clinical trials across borders, CSOFT Health Sciences specializes in patient diaries translations in 250+ languages.
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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 a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And 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. Every step of the way, CSOFT has you covered.
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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 best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.
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