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OCT Clinical, a full-service European CRO, has obtained a CTA approval to run a bioequivalence study. The sponsor of the study is a European innovation-driven speciality pharmaceutical company which distributes products in more than 100 countries worldwide.
The aim of the study is to establish the interchangeability of the investigational medicinal product active substance with that of a reference medicinal product. According to the study Protocol, 70 healthy volunteers are to be screened, and 60 of them will be randomized and included in the study. Subjects will undergo four periods of therapy at one specialized investigational center.
'We are confident that our thorough expertise will allow us to meet all the Sponsor's goals. Our next milestone is the successful completion of the clinical stage of the study,' - commented Project Manager at OCT Clinical.
OCT Clinical services range from medical writing, regulatory services and site monitoring to biostatistics, data management and logistics.