As new medical treatments enter global markets, clinical study report translations are needed to analyze the methods and outcomes of clinical studies conducted in multiple languages. As clinical research organizations continue to release applications to access foreign markets for new medical treatments, complying with global regulatory standards is vital to ensure credibility. With a worldwide team of 10,000+ in-country linguists and subject matter experts, CSOFT’s translation and interpreting support in over 250 languages enables growing healthcare and research organizations to deliver clinical study report solutions across language barriers.
Clinical Outcome Assessment Translations
Clinical outcome assessment translations are essential in reporting a patient’s clinical study experience in relation to their feelings, functionality, or survival. A rigorous linguistic validation process must be performed to ensure the quality and validity of the assessment. All COAs must be translated and validated through a clear linguistic validation process by an experienced team of professional linguists, subject matter experts (SMEs), and project managers. CSOFT works with life science companies involved in the drug development process to ensure the highest-quality COA translation and linguistic validation process. Our methodology follows the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) workflow guidelines and recommendations, ensuring harmonization for regulatory bodies, sponsors, patients, and drug developers.
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Ensuring Global Compliance in Clinical Trials
The rise in international clinical trials has escalated the demand for multilingual translations of patient-reported outcomes (PROs), which are crucial for meeting regulatory requirements and trial endpoints. As a direct measure of patient health reported by the patients, PROs, including ePROs, are critical in assessing treatment effects on quality of life and symptomatology. Our translation services guarantee that these vital documents are accurately translated, facilitating the safe introduction of new medical interventions to global markets.
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Drug Development Process Documentation Translations
Drug development is an integral part of global clinical studies, and drug development process documentation translations are necessary to adhere to regulatory standards and access markets worldwide. Whether for a pharmaceutical company, clinical research organization, the U.S. Food and Drug Administration (FDA), or the European Union (EU), process documentation ensures that drugs going through all development cycle phases meet necessary regulations to ensure safety and efficacy.
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Outcomes Research Document Translations
As global healthcare systems continue to shift towards providing cost-effective, high-quality, and patient-focused care, it is equally important that the impacts of intended health treatments and interventions be accurately assessed through outcomes research document translations. Outcomes research is a field of public health that combines different aspects of healthcare and quality of life assessments to better understand the results of healthcare initiatives within a society. During outcomes research, tangible results are achieved by assessing different outcomes of health initiatives, such as the morbidity and mortality rates, effectiveness, efficiency, cost, timeliness, or system responsiveness. Over time, outcomes research is used to develop new strategies for improving public health initiatives and increasing the overall health of a society. To successfully conduct and report outcomes research in clinical study reports, translations are essential for reaching linguistically and culturally diverse communities as well as implementing new public health initiatives on a global scale.
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Drug Trial Protocol Translations
To help facilitate the process of approving potential new medications, ensuring that all trial procedures adhere to regulatory standards demands high-quality and accurate drug trial protocol translations. Protocols for pharmaceutical products in clinical trials are designed to standardize the study’s objective, design, safety measures, organization, statistical analysis, and other key aspects to ensure that trial replication can succeed and be held to the same standards. Drug trial protocols also play an important role by establishing a clear and descriptive document that can be assessed by a regulatory body while remaining in compliance with Good Clinical Practice (GCP) guidelines and are an essential clinical document required in Trial Master Files (TMFs/eTMFs) submissions. For any pharmaceutical company conducting international clinical trials, drug trial protocol translations are necessary for ensuring the safety of trial participants and for upholding the integrity of the data being collected. To facilitate success in developing new pharmaceutical products and reaching new markets,
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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.
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