Sanna G. Sboeva, Yuliya A. Klyueva, Nikolay I. Burdaev, Maksim A. Zaharchenko

Abstract

The author justified the need to develop a scientific and methodical approach to the management by pharmaceutical company activities during the conduct of clinical trials. In this regard, the aim of this study was to build a model for business process modernization and evaluate its effectiveness. A clinical trial of the 3^rd phase of an innovative antidiabetic drug was chosen as the model object of the study. They used the IDEF0 (Integrated Definition Function Modeling) method in the work, accepted as the state standard in the USA and as the recommendations of RF Gosstandart Р 50.1.028-2001. CASE (Computer-Aided Software/System Engineering) means ERwin Process Modeler r7.3 was selected as the tool for analysis, organization, and reorganization of business processes. During the evaluation of the effectiveness of the clinical trial management system, the authors used the net present value (NPV) calculation method.The article proposed the methodological principles of management optimization, which included the construction of two models of business processes in the clinical studies of a pharmaceutical company before and after modernization ("AS-IS" and "AS-WILL"). The structure of the AS-WILL model has a new functional unit "To support clinical research", which can allow organizing the company activities more efficiently through the introduction of highly specialized positions - a logistics expert and an expert in regulatory procedures. For the economic evaluation of modernization, negative cash flows were taken into account and distributed throughout the quarters during the clinical study, a discount rate was determined depending on the projected risks and NPV value was calculated. The authors found that the business process model including the "Clinical Research Support" unit, can increase net present value‎.