What are Clinician-Reported Outcomes (ClinROs), and why are their translations so important for companies conducting clinical trials? ClinROs are valuable assessment reports written by a clinician or trained health care professional and are used to document measurable changes in a participant’s overall health, symptoms, quality of life, and ability to function during a clinical trial. With more clinical trials being conducted overseas and the importance of accurately documenting clinical outcomes across languages, high-quality and accurate clinician-reported outcomes translations are vital to meeting the needs of all stakeholders in the clinical trial process.
To help clinicians and medical professionals accurately document changes to a patient’s health across any language and meet international language requirements for clinical trial documents, CSOFT Health Sciences provides high-quality and cost-effective ClinRO translations in over 250 languages. With a global network of 10,000+ in-country 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 and also to evaluate the quality of care provided during the trial. Patient diaries are important communications often fraught with misunderstandings, requiring expert translation to be applied effectively and ethically in diverse trials. CSOFT’s expertise in translating and localizing patient diaries for companies conducting clinical trials can solve these communication problems and help expand a trial’s scope across borders.
Learn more about our patient diaries translations.
Case Report Form (CRF) Translations
During a clinical trial, a case report form (CRF/eCRF) is an essential tool the trial sponsor uses to record and collect data on each trial participant, making CRF translations necessary for sponsors conducting trials across borders to reach patients in multiple languages. To help the sponsor support and test their hypothesis, a CRF is created and used to gather 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 and engage patients across languages and to help sponsors comply with Institutional Review Board (IRB) guidelines, CSOFT Health Sciences provides professional and high-quality CRF translations, ensuring that the already-complex trial process isn’t complicated by miscommunication.
Learn more about our case report form (CRF) translations.
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 COAs are accurate in all languages.
Learn more about our linguistic validation for COAs.
Streamlining Global Reach with Clinical Study Report Translations
With the expansion of new medical treatments worldwide, the need for clinical study report translations grows to facilitate the analysis of study methods and results. As organizations seek to introduce novel treatments to international markets, adherence to global regulatory standards is paramount to ensure trustworthiness. CSOFT Health Sciences leverages a global team of in-country linguists and subject matter experts to deliver high-quality, tailored medical translation and localization solutions for clinical study reports.
Learn more about our clinical study report translations.
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 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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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 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.
Learn more about how CSOFT prioritizes data security.