As clinical trials grow in usage and scale worldwide, Observer-Reported Outcome (ObsRo) translations have become essential for Life Sciences companies. ObsRos are a type of clinical outcome assessment (COA) that differs in one fundamental way from their brethren – they are assessments done by a trusted observer of the subject, be it a family member, friend, legal guardian, or someone assigned to them. Their observations allow for a more comprehensive view of a subject’s condition or performance for those conducting the trial. They are a vital form of documentation for all stakeholders or regulators, given that they can provide intimate information that may not be self-reported by the subject or observed first-hand by clinicians.
For any cross-language study, having a qualified language service provider (LSP) in one’s corner is invaluable. As they are often reported by observers who speak the same language or dialect as the subject, ObsRos can be filled with nuance and subtleties, and an imprecise translation can imperil an entire study when the most granular details are of significance. With our network of skilled linguists and subject matter experts, CSOFT Health Sciences can help companies conducting international clinical trials ensure that their ObsRos are accurate, precise, and delivered quickly.
Performance-Reported Outcomes (PerfOs) Translations
Much like ObsRos, Performance-Reported Outcomes (PerfOs) offer a unique perspective in clinical trials. They gauge 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 COAs to meet trial endpoints, multi-language Patient-Reported Outcome (PRO) translations have become 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, and 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. 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.
Learn more about our PRO translations.
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.
Learn more about our ClinRO translation services.
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.