The past decade has witnessed a rapid expansion of clinical trial market into diverse cultures and languages. This development has increased awareness of the complexity of running global clinical trials and resulting language challenges. The issue of language is particularly critical as accuracy of research and drug development process is key to achieving successful results.
Pharmaceutical companies and clinical research organizations (CRO) that perform clinical trials outside of the United States, governed by guidelines and standardized practices, face the need to translate a broad range of documents. Typically they include: Clinical Study Protocols and Case Report Forms (CRFs, eCRFs), Patient Informed Consent Forms (ICF), Patient Diaries, Patient Information Materials, Preclinical through Phase IV Documentation, Quality of Life Scales, Questionnaires, and Patient-Reported Outcomes (PRO, ePRO).
Translation of clinical trial materials has, therefore, become an indispensable component of any clinical trial being conducted on a global scale. This highly detail-oriented process requires the expertise of professional translators who are not only experienced in the use of medical terminology, but also understand that as the trial protocols become more complex, medical terminology intermingles with administrative and technical jargons.
Here, at eclipse, we chose to partner with TRANSPERFECT in order to provide assistance to our clients with over 170 languages worldwide. A typical service call will unfold in a straightforward and easy manner. From start to finish, our members of the support team will ask the client to hold while they connect to an interpreter, enter a pin and request the required language. Then, they will explain to the interpreter what type of assistance the client needs. From that point, all three parties, work together to answer questions and provide feedback in the quickest and most effective manner.
While the main purpose of language translation is to make sure that the documentation provided is readily understood within the cultural context, we can’t ignore the benefit of avoiding potentially costly delays.
With the ever increasing demands from regulatory bodies for greater scrutiny over clinical trials, associated costs and risks are also likely to increase. As a company committed to doing the right thing for our clients, we always look for efficiency wherever we can find it, and language translation offers a key advantage by guaranteeing accurate, quality data.
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