Abstract

In this study, an expert evaluation of the clinical trial management model with an optimized regulatory system at the level of a contract research organization was conducted. The model was developed within the dissertation research regarding the impact of the regulatory system on the management of clinical trials in Ukraine. Six experts in the field of clinical trials (regulation, organization, and execution of clinical trials) were involved in the expert assessment using a semistructured interview method following the guide. The article presents the results of the expert evaluation and conclusions regarding the adaptation of clinical trial management model with an optimized regulatory system at the level of a contract research organization, considering expert opinions.

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