Clinical Study Protocol Translation; CSP Translation

Translation services are becoming an indispensable component along with the increasing demand for conducting multi-country clinical trials. The clinical trial follows a carefully controlled protocol, a study plan that describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Clinical Study Protocols (CSPs) assist communication among all the people working in the trial and can be regarded as a “written agreement between the investigator, the subject, and the scientific community.” Each protocol describes the objectives, design, methods, statistical aspects and organization of a trial. Well-written CSPs are essential to the conduct of successful clinical studies.