January 15, 2005 | International clinical trials require a stringent review process for translating label instructions into various languages, where quality-assurance personnel review labels for culturally appropriate layout and context, as well as translation accuracy. Traditionally, this review process can take several weeks. To speed things up, the drug company implemented a validated IT solution to ensure that translations accurately reflect label directions, regardless of language. Using new labeling technology, the company built a comprehensive library containing approved translations for text commonly found on product labels.
The automated system works by attaching a unique identifier to a variety of common label instructions - phrases such as "Take two pills per day." For each clinical trial, phrases and languages are selected from the library, and the system automatically applies pre-approved and validated translations for specific labels. The company successfully used the system to slash the label-translation process - from 35 days to three days.
As industry estimates put the cost of clinical trials at roughly $1 million a day, shaving 32 days from the labeling process yields savings for all phases of a clinical trial in excess of $100 million.
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