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Language challenges in global clinical trials

Research in medicines is an ongoing process. Growing need and awareness among the population for health care over the years has influenced research and development process of pharmaceutical and medical industry. Newer and effective approaches in screening, diagnostic, treatment and prevention have been identified to replace or improve older ones.

In today’s changing economic and political environment, there is enough interest driving pharmaceutical players to explore newer countries to conduct the research and development activities. Gone are the days when clinical trial and research on human volunteers was a known practice in countries like Europe and USA. Asian countries like India and China emerged as one of the fastest growing destination for various global clinical trials & bioequivalence studies in past some years due to advantages of low cost and quick recruitments of subjects. Along with opportunities, there exist some challenges for these markets, like ethical conduct of the research; cultural and language barriers. This has increased the requirement of service providers who have closely worked in these markets and have expertise and competence to overcome these issues by providing quality and timely services for conduct of global clinical trials.

While conducting Global clinical trials, translation of the documents in multiple languages, especially to local languages of the site/country of trial is essential and inevitable. Documents like Patient Information Leaflets (PIL), Informed Consent Forms (ICF), Doctor and Patient Guides, Case Report Forms (CRF), Patient Questionnaires, Drug Inserts, Drug Study Labels, Clinical Protocols, Regulatory Documents Trials may require translation to many of the regional languages such as Hindi, Marathi, Panjabi, Malayalam, Oriya, Tamil, Telugu, Urdu, Assamese, etc. Quality language translation of documents is required to simplify the process and to meet the regulatory requirements effectively. This creates a need of professional translation service providers specialized in pharmaceutical and medical research. Moreover, expansion of the EU block into new member countries is also driving increased demand for medical and pharmaceutical translation services. Translation services can be required at various stages including clinical research, regulatory submission and review, production and marketing. Study related documents (like COAs) from other countries are required to be translated to English (from Portuguese, French, German, etc) to conduct and document the studies as per country/CRO specific requirements.

During past some years Translingua is recognized among pharmaceutical players as professional translation service provider following global standards of practice.

About Translingua:
Translingua is a translation services provider in the area of Clinical & Medical Research serving pharmaceutical, biotechnology, CRO, Medical Device & Medical Writing Companies.

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