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Friday, June 22, 2012

Tips to get accurate clinical research translation

If you go through a container of one of your prescription medicines, you'll find several types of information on it- dosage and frequency of use, side-effects, storage instructions, warnings etc., mostly in more than one language. As the countries all over the world drop barriers in order to make way for trades and treaties, drugs and devices are also finding their place in export/ import. Translation business, therefore, has inadvertently become a path-breaking venture when dealing with pharmacology and clinical research. The companies offering translation services to healthcare and life science industries are enjoying the attention and demand they are being catered. However, this wide gamut of opportunities for translation companies, assumes a certain amount of expertise at the core. Here are some tips that have to be kept in mind while clinical research translation.

Even though English is touted as the official language around the world, it's unprofessional to assume that English-language labels will work in every foreign country. There are several directives in the European Union countries, such as, Medical device directive(MDD) and In-vitro diagnostics directive(IVDD), which make it mandatory for clinical/medical labels to be translated in the native language of the country in which they are being sold or tested.

Apart from the translation of various medical documents such as clinical trial documents, pharmacology test reports, instruction manuals, patient's records, packaging labels of medical equipments, medical questionnaires etc., translation service providers are also finding opportunity in translating Informed consent forms (ICF) these days. Their format is very technical and should be dealt with utmost care. Any unclarity in meaning would also result in violation of FDA regulation that "the information shall be in language understandable to the subject or the representative".

Another very important aspect that should be kept in mind is to avoid using canned machine translation programs as any kind of error-major or minor, can lead to grave consequences. It's always advisable to work with professional translators having a decent amount of work experience in clinical research and pharmaceutical interpretation. Using Translation Memory (TM) tools can also be an option worth considering since it assures consistency of terminology, expedite future ICF revisions, and reduces translation costs, however, these tools should not be confused with Machine Translation (MT) software. To make the translation task easier when too many countries are involved at a time, the labeling and packaging can be done according to their geographic similarities. For eg- the drugs for countries under NAFTA (United States, Canada, and Mexico), are labelled in English, French, and Spanish languages. Having a personnel, thoroughly informed with clinical resear ch- related regulations in a foreign country can save you any legal mess and delay of your product marketing.

Hence, it's always fruitful to go with the best of the lot, so hiring hardcore professional interpreters would ensure the best quality of translation along with cost-effective methods.

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