Building upon last week’s post around the revision to MEDDEV 2.7/1, I wanted to take a quick look at contract research organizations (CROs) and their usage of translation services.
Clinical trials are expensive and multi-faceted, as a consequence it is very common for companies to outsource trials to CROs as an efficient method to reduce costs. To market a new product in Europe that was manufactured in the United States, the product may need to be translated into the 23 or more languages that make up the European Union. Before that new product can ever be marketed, there are many further obstacles to overcome such as guidelines and regulations for each of the countries these trials are conducted in.
In addition to the complicated process of conducting global clinical trials, critical translation is happening all along the way. The process of localization is complicated but necessary, as mistakes can be disastrous. CSOFT’s article Clinical Research Organizations and the problem of medical translation breaks down these issues including cognitive debriefing which ensures the reliability, conceptual equivalence, and content validity involved in the translation of patient-reported outcome measures.
The necessity for CROs to receive high-quality medical translation for trials is essential. As the world’s life-expectancy rate continues to climb and clinical research produces more cures and treatments, each will need to be translated, tested, and approved in their respective countries. Contract research organizations will require specialized translation expertise to handle their document localization.
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