In addition, with a global network of 10,000 linguists and subject matter experts, we provide a range of COA translations, including patient-reported outcome (PRO) translations, performance-reported outcome (PerfO) translations, and observer-reported outcome (ObsRO) translations.
Patient Diaries Translations
Patient diaries are an essential tool that enables clinical trial participants and patients to accurately document patient-reported outcomes (PROs). Using a patient diary, the study subject or patient may be asked to record information like adverse events, symptoms, or medication dosage times. For anyone conducting cross-border clinical trials or in need of translations of patient diaries, CSOFT Health Sciences offers professional and high-quality patient diary translations in more than 250 languages.
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Case Report Form (CRF) Translations
During a clinical trial, a case report form (CRF/eCRF) is an essential tool used by the trial sponsor to record and collect data on each trial participant, which makes CRF translations necessary for sponsors conducting trials across borders and needing to reach patients in multiple languages. To help the sponsor support and test their hypothesis, a CRF is created and used to gather the vital patient information, which can range from a small collection of notes to high volumes of clinical notes and patient data. With a growing demand to reach patients across languages and to help sponsors comply with global Institutional Review Board (IRB) guidelines, CSOFT Health Sciences ensures professional and high quality CRF translations.
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Linguistic Validation for COAs
For stakeholders involved in global clinical trials, many regulating bodies require documents like patient questionaries, which are used to record clinical outcome assessments (COA), to be submitted for review in particular languages. With a growing number of sponsors conducting clinical trials internationally and involving patients of all backgrounds, ensuing that patient questionnaire translations are consistent and accurate is essential for successfully bringing the new products to market and completing the trial within a reasonable time frame. Using a multistep process called linguistic validation that combines the knowledge of linguists and medical experts, CSOFT Health Sciences can help sponsors and other trial stakeholders ensure their patient questionnaires and COA needs are accurate in more than 250 languages.
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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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