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Informed Consent Form Translations

We provide fast and accurate informed consent form translation and interpretation solutions for patient informed consent forms to help you cross linguistic barriers worldwide

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Worldwide informed consent form translation needs

The precise translation of informed consent forms is essential to safeguard patient safety and the legal integrity of healthcare professionals and life science businesses. Improperly translated forms may lead to uninformed decisions by patients, potentially resulting in malpractice lawsuits. For patients with limited or no proficiency in English, accurate translations are crucial to ensure their comprehensive understanding of regulatory requirements. This fosters clear communication between patients and healthcare professionals regarding treatments and potential side effects, promoting a thorough grasp of patient health and safety. With a global team of 10,000+ in-country linguists and regulatory specialists, CSOFT Health Sciences can help assure regulatory submission compliance while providing the highest-quality informed consent form translation and localization solutions, ensuring patient protection on a global scale.

Interpretation Services

While accurately translated informed patient consent forms are necessary before medical procedures, healthcare professionals must also communicate with patients about the benefits and risks of treatment options. These conversations require the expertise of qualified medical linguists to ensure accurate interpretation of any relayed information and any questions or concerns between patients and physicians.

CSOFT linguists are in-country native speakers with professional experience in life science industries. Our subject matter experts can provide in-person and over-the-phone interpretation solutions for your business needs in over 250 languages.


Digital informed consent form translation

Informed Consent Form Formatting

Challenges such as expansion or contraction may arise in the translation process. Properly formatting patient informed consent forms after translation is crucial to mitigate the risk of patient misunderstanding and ensure that the information is accurately presented. Our expert multilingual desktop publishing (DTP) team collaborates with various file formats to adhere to international typographic regulation protocols, including MS Word, PowerPoint, Adobe, InDesign, PDF, and more. Additionally, we employ Linguistic Validation and Terminology Management through our AI and Cloud-based solutions.

Patient Information Sheet Translations

As clinical studies expand globally, it becomes crucial to translate patient information sheets to exchange and utilize patient data in future research studies. Effective communication between patients and providers is fundamental in healthcare treatment, and inaccuracies in translations can result in false information or sharing confidential details without the patient’s consent. Whether you are a healthcare provider, patient, or clinical research organization, patient information sheets must be in regulatory compliance to ensure patient data privacy. 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.

Read more about our patient information sheet translations.

Patient Portal Translations

Keeping patients informed of trial results and other data is an important part of maintaining informed consent. Online patient portals are emerging as a leading patient communication and engagement solution in healthcare and clinical trials. These platforms enable patients to access crucial health information and records anytime, allowing them to view and submit necessary medical or clinical trial documentation, such as questionnaires and recruitment material. Accurate translations for patient portals are imperative to reach patients on a global scale and effectively communicate with patients from diverse backgrounds. CSOFT Health Sciences’ global network of linguists and subject matter experts have experience with high-quality translations of patient-facing materials and digital health platforms. To increase patient retention and boost recruitment, our patient portal translations enable companies and healthcare providers to reach new markets, end users, and patient populations. 

Learn more about our patient portal 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.

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 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.


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