Performance-Reported Outcomes (PerfOs) offer a unique perspective in clinical trials, gauging a patient’s health through their task performance, rather than individual or self-reported assessments. As such, accurate translations of PerfOs are essential for multinational trials involving diverse linguistic groups. These translations provide crucial transparency to regulatory bodies, drug developers, 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 over 250 languages. Through these translations, developers can 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 utilized to note health outcomes such as symptoms, quality of life, adverse responses to treatments, along with patient’s 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.
Learn more about our PROs translation services.
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 a valuable assessment report 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.
Learn more about ClinRO translation services.
Clinical Study Reports Translations
As the global footprint of medical treatments widens, the translation of clinical study reports becomes critical to understanding the strategies and results of these studies. With clinical research bodies consistently introducing new therapeutic applications to penetrate foreign markets, adherence to international regulatory norms is imperative to maintain 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.
Learn more about our clinical study report translations.
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.
Learn more about our CRF translations.
Clinical Trial Protocol Validation
Clinical trial protocols are crucial documents that aim to describe the objective, study design, safety measures, organization, and other important aspects of how the trial will be conducted. 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 a necessary step to gain approval. CSOFT Health Sciences specializes in technical translations for a wide range of clinical trial documents and our team of over 10,000 subject matter experts and in-country linguists ensure that translations are done in a professional and timely manner.
Learn more about our clinical trial protocol translations.
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.
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 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.
Learn more about our quality assurance process.
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.