Medical research – also called experimental medicine or biomedical research – is a broad field, including everything from clinical research and applied research to translational research and basic research (also known as bench research or bench science). As the demand for healthcare products grows overseas, many types of medical research, such as clinical trials, are increasingly conducted in regions where English is not the dominant language. In order to conduct effective medical research in an increasingly global environment, life science companies and research institutions must have highly accurate and timely translations for medical research documents such as informed consent forms. With a global network of 10,000 linguists and subject matter experts, COSFT provides high-quality and technically accurate multilingual translation solutions for medical research documentation across 250+ languages, from patient information sheets and research protocols to Phase 0-IV clinical trial documentation and IEB/IRB documentation such as AEs/Ars/SAEs/SUSARs.
Clinical Trial Documentation Translation
Conducting clinical trials and clinical studies is a core part of clinical research. To meet the growing demand for pharmaceutical products and medical devices, more and more clinical trials are being conducted overseas. To ensure that the clinical trial is conducted according to protocol, and that enough participants can be recruited, highly-accurate and culturally sensitive clinical trial documentation and patient recruitment material. CSOFT’s network of 10,000+ professional medical translators have the linguistic and regulatory expertise and qualifications to help organizations achieve international compliance with accurately translated clinical trial documentation and patient recruitment material.
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If an adverse reaction occurs during clinical research, it is imperative that adverse events and adverse reactions (Ars), serious adverse event (SAEs), and suspected unexpected serious reactions (SUSAR) must be reported immediately to relevant regulatory agencies and institutional review boards (IRB) as well as institutional ethics board (IEB). Because these documents are critical for ensuring drug or product safety, it is vital that they are translated with the highest degree of accuracy with a fast turnaround time. CSOFT’s team of subject matter experts can translate all types of pharmacovigilance documents accurately and in a timely manner, allowing researchers to maintain regulatory compliance and quickly identify and report adverse events.
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When conducting research, protecting personal information and sensitive health data is of the utmost importance. CSOFT has 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.
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In medical research, using highly-accurate research documentation is vital; one wrong translation could mean an incorrectly conducted experiment, or worse, accidental death in patients. CSOFT understands the importance of providing the most accurate and high-quality translation solutions for life science companies, and is dedicated to ensuring the highest-quality communication solutions for patient recruitment and additional clinical trial phases. To ensure we provide the highest-quality communication solutions available, CSOFT uses in-country linguists with a minimum of 7 years of experience, and an extensive network of subject matter experts. In addition, CSOFT implements localization best practices such as linguistic validation, back translation, and terminology management, helping life science companies reach patients globally.
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