Medical Translation Services

Digital Health Translation Solutions

As we shift towards a more digital and virtual world, life science companies are working to change the way they handle sensitive information and documentation, as well as interact with patients. By doing so, this also allows for a more streamlined and connected experience for patients as well as doctors and healthcare professionals as healthcare organizations transfer their data and content to a digital platform. Particularly in these unprecedented times, due to COVID-19, digital health has become more important than ever to allow for social distancing between patient and healthcare professionals through telehealth, telemedicine,  mobile health (mHealth), wearable devices, and health information technology (IT). For this information to be validated, however, it must be accurately translated in accordance with local regulatory policies.

Pharmaceutical Translation Services

As the pharmaceutical industry continues to innovate groundbreaking drug therapies and medical products all over the world, the need for medical translation and localization for a variety of pharma documents are necessary for pharmaceutical companies to succeed in international markets. With an increasing number of clinical trials being conducted overseas, and a growing demand for products at a global scale, effectively translating medical content requires expert linguistic validation and straightforward management solutions for every step of the product lifecycle.

CSOFT provides expert pharmaceutical translation solutions for every step of the product’s life cycle. Our expert linguists have extensive knowledge of international regulatory policies to ensure your product’s success in the international market.

We translate:

• Clinical Research Studies
• Clinical Outcome Assessments(COAs)
• Drug Trial Protocols
• Patient Informed Consent Forms (ICFs)
• Regulatory Submission Documents
• Drug Trial Protocols

Learn more about our pharmaceutical translations.

Medical Translations for Clinical Trials

In recent years, clinical trials are increasingly conducted in oversea markets. This means that translation and localization have become essential in the clinical trial process to accurately represent both the participant in the study as well as the healthcare organization conducting it.

Regardless if you’re a contract research organization (CRO), Institutional Review Board (IRB), or hospital, CSOFT has you covered for all your clinical trial translation projects. Our cloud-based management system helps streamline project management and the translation process, so all files and documents are in one place.

Learn more about our clinical trial translations.

Good Documentation Practices Translations

Good Documentation Practices (GDP), also referred to as GDocP, describes a set of standards that are designed for the pharmaceutical and medical device industries and required by most regulatory bodies including the FDA, EMA, TGA, and more. These procedures are typically carried out electronically, and mandate life science companies to keep a variety of documented records throughout the product’s lifecycle. High-quality good documentation practices translation is essential for international regulatory compliance.

CSOFT’s cloud-based translation management system ÜbrTà streamlines the document management process to allow companies in the life sciences to hold all their GDP documents in one place. Our team has in-depth knowledge of good documentation best practices and is experienced with translating a wide variety of file types.

Learn more about our GDP translations.

Regulatory Translations

Across life science industries, meeting regulatory compliance standards is an essential step in gaining market access. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and China’s National Medical Products Administration (NMPA) all require data and documentation to ensure the efficacy and safety of products entering the local market. To gain regulatory compliance, accurate translation of regulatory documentation and data is critical for life science companies to be successful when expanding overseas.

Learn more about our regulatory translations for life science companies.

Informed Consent Form Translations

Accurate translation of informed consent forms is imperative in protecting both the patient’s safety and the legal security for healthcare professionals and businesses in the life sciences. Informed consent forms that are not properly translated can result in a patient making an uninformed decision, which can lead to malpractice lawsuits. Patients that do not understand English well or at all must have accurately translated versions of these forms to ensure their full comprehension of the regulatory requirements. This also helps provide clear communication between the patient and their physician or healthcare professional regarding treatments and potential side effects for patient health and safety understanding.

Learn more about our informed consent form translations.

Data Security and Privacy

We have well-documented and fully traceable information security policies, checklists, and quality records. CSOFT understands the importance of security to our clients and we take nothing for granted when confidentiality is a concern. All our data and security processes comply with our certified ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001.

Learn more about our data security.