Performance-Reported Outcomes (PerfOs) offer a unique perspective in clinical trials, gauging a patient’s health through task performance rather than individual or self-reported assessments. Accurate translations of PerfOs are essential for multinational trials involving diverse linguistic groups. These translations provide crucial transparency to regulatory bodies, drug developers, and patients about clinical endpoints and are often mandatory by regulatory bodies such as the FDA and EMA. Moreover, they inform all stakeholders about potential ways to enhance patient care and contribute to informed public health decisions.
CSOFT Health Sciences delivers high-quality PerfO translations in 250+ languages. These translations can help developers enhance the efficiency of the trial treatment, optimize patient experience, and fulfill the regulatory need for appropriate regulatory submissions.
Patient-Reported Outcomes (PROs) Translations
As clinical trial sponsors strive to adhere to international standards for Clinical Outcome Assessments (COAs) to meet trial endpoints, multi-language PRO translations have emerged as a crucial tool for stakeholders and industry sponsors in trial results. Among various types of COAs, PROs are self-reported clinical measures recorded by the patient. They are used to note health outcomes like symptoms, quality of life, adverse treatment responses, and patient self-evaluations of healthcare. Often digitally recorded as ePROs, PROs are indispensable for many clinical trials, ensuring safe market entry for new medications and products. To help sponsors and clinical trial stakeholders document and submit PROs in multiple languages, CSOFT Health Sciences offers professional and high-quality PRO translations from our network of subject-matter experts and qualified linguists.
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Clinician-Reported Outcomes (ClinRO) Translations
With more clinical trials being conducted overseas and the importance of accurately documenting clinical outcomes across languages, high-quality and accurate clinician-reported outcomes (ClinRO) translations are vital to meeting the needs of all stakeholders in the clinical trial process. ClinROs are valuable assessment reports written by a clinician or trained health care professional. They document measurable changes in a participant’s overall health, symptoms, quality of life, and ability to function during a clinical trial. CSOFT Health Sciences works with life science companies involved in drug development to ensure the highest-quality ClinRO translation and linguistic validation process for multilingual, flexible clinical trials.
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Clinical Study Reports Translations
As medical treatments’ global footprint widens, translating clinical study reports becomes critical to understanding their strategies and results. Clinical research bodies consistently introduce new therapeutic applications to penetrate foreign markets, so adhering to international regulatory norms is imperative to maintaining credibility. CSOFT Health Sciences, with its 10,000+ worldwide network of expert linguists and subject matter specialists, offers top-tier tailored translation and localization services for clinical study reports.
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Case Report Form (CRF) Translations
Case report forms (CRFs) are crucial documents trial sponsors use during a clinical trial to collect patient data for hypothesis testing and 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 increasing clinical trials being conducted across multiple languages, CRF translations are necessary for regulatory compliance and ensuring 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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Clinical Trial Protocol Validation
Clinical trial protocols are crucial documents that describe the objective, study design, safety measures, organization, and other essential aspects of conducting the trial. For anyone conducting clinical trials overseas and in compliance with global regulatory standards, ensuring the highest quality translation for clinical trial protocols with linguistic validation may be necessary to gain approval. CSOFT Health Sciences specializes in technical translations for various clinical trial documents.
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Case Report Form (CRF) Translations
Case report forms (CRFs) are crucial documents trial sponsors use to collect patient data for hypothesis testing and data analysis during a clinical trial. 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 increasing clinical trials being conducted across multiple languages, CRF translations are necessary for regulatory compliance and ensuring that 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.
Learn more about our CRF 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 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.
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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 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.