As clinical trials continue their current course of global expansion, translation has become a critical component in developing patient recruitment materials. But all translation companies are not created equal. Before hiring a vendor to translate your clinical trial content, consider asking the following key questions:
1. Where are your translators based? Some translation providers have credentialed linguists in every conceivable corner of the world. Others have U.S.-based linguists who not only speak the language, but understand colloquialisms and cultural nuances. Irrespective of locale, their ultimate objective should be to provide translations that are linguistically sound, culturally savvy, and consistent with the study brand.
2. Are your translators generalists or industry specialists? Linguists do more than convert words from one language to another – software can do that. Given the regulatory complexities of patient advertising, life-science translation requires skill not usually found among generalists. Sponsors increasingly seek providers with linguists who translate exclusively for the life sciences, and can adapt their translation for both patient and physician audiences.
3. Is your translation provider certified? International Organization for Standardization (ISO) certification is a designation reserved only for translation providers meeting the highest global standards. Certification is a rigorous process involving third-party assessment of company processes and procedures, including quality control, record keeping and client communication. It typically takes more than a year to complete. There are other certification programs similar to ISO, so do your homework.
With patient materials subject to intense regulatory scrutiny, mistakes in translation can multiply exponentially according to the number of countries and languages involved. Managing translation as an outsourced function becomes more challenging if a sponsor’s patient recruitment provider uses a third-party translation vendor. In this scenario, the sponsor’s ability to effectively assess quality and internal controls can be hampered significantly, with every level of management and review filtering the flow of communication and obscuring outcomes. It may be preferable for a trial sponsor to hire a Functional Service Provider (FSP) that offers a full suite of services, including translation. Companies such as this feature unified standards, central management and streamlined client communication. Other benefits of an FSP include increased quality control, better communication and efficiency, and consolidated file management and version control.
