As clinical studies continue to grow worldwide, patient information sheet translations enable the exchange of patient information across diverse regions and languages and utilize patient data in future research studies. Communication between patients and providers is essential in healthcare treatment. Inaccurate translations can have consequences, such as exchanging false information or sharing confidential information without the patient’s consent. Thus, whether you are a healthcare provider, patient, or clinical research organization, all applicable patient information sheet translations need to be in regulatory compliance to ensure patient data privacy and the success of your study.
With a global team of 10,000+ in-country linguists and subject matter experts, CSOFT Health Sciences provides high-quality customized medical translation and localization solutions for patient information sheets. From clinical studies to patient-provider interactions, CSOFT’s translation and interpreting support in over 250 languages enables growing healthcare and research organizations to deliver patient information sheet solutions across language barriers.
Healthcare Document Translations
Even as the patient information sheet provides crucial details of the patient’s demographics, medical history, and past treatments, translations of healthcare documents are necessary to understand a patient’s well-being and best treatment options thoroughly. As patients across the globe continue to seek treatment, there is an even more pressing need to develop culturally sensitive, well-localized content to limit any confusion between healthcare professionals, providers, and patients. With a global network of skilled linguists and subject matter experts, CSOFT Health Sciences offers a full range of medical translation solutions for every healthcare document.
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Digital Healthcare Document Translations
As healthcare shifts to utilize digital health tools globally, translating digital health documents is crucial to ensure safe information exchange when sharing patient information sheets across providers and research organizations. Digital health and the tools it employs have the potential to provide more patient-centric care by enhancing patient care and improving diagnosis and treatment accuracy. CSOFT Health Sciences has decades of experience working with life science companies involved in telehealth care and solutions – let us help you better serve your patients.
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Medical Document Translations
As life science companies grow globally, accurate translations of medical documents, from patient information sheets and medico-marketing materials to clinical service agreements and standard technical documents (CTDs), are crucial for gaining market access and complying with local regulatory requirements.
Whether you are a medical device manufacturer, pharma retailer, medical distributor, or involved in bio-medical engineering, CSOFT Health Sciences has the experience and resources to ensure highly accurate translation solutions for all types of medical documents.
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Informed Consent Forms Translations
Accurate translation of informed consent forms is essential to safeguard patient information and the legal security of healthcare professionals and businesses in the life sciences. Informed consent forms are crucial in clinical research and medical practice, ensuring that patients or research subjects comprehend the procedures. Improperly translated forms can result in patients making uninformed decisions, leading to mistrust, inaccurate data, malpractice lawsuits, and more. Limited English Proficiency (LEP) patients require accurately translated versions of these forms to understand regulatory requirements fully. This ensures clear communication between patients and their physicians or healthcare professionals regarding treatments and potential side effects, promoting understanding of patient health and safety. CSOFT Health Sciences can facilitate regulatory submission compliance while delivering the highest-quality translations and localization solutions for informed consent forms, ensuring patient protection on a global scale.
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Institutional Review Board (IRB) Correspondence Translations
As research in the health science industry continues to expand globally, translations of Institutional Review Board (IRB) correspondence are essential to protecting human rights in clinical trials. Documents, including IRB protocol, amendment, and progress report forms, must also be translated and localized to meet international regulatory standards to access foreign 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.
Learn more about how CSOFT prioritizes data security.