Centro de pesquisa clínica: estrutura e administração

Abstract

The aim of this work, built from bibliographical research, is to present basic guidelines that serve as support for a model of physical and organizational structure, and method of administration, to be implanted in a Clinical Research Center, public or private. The clinical trials or studies constitute the most expensive and time-consuming part of the drug development process. It usually takes place at a Clinical Research Center, a public or private organization legally constituted and authorized to perform clinical research. The set of rules and proceedings together with the material resources (buildings, equipments, etc.) form the structure of an organization. The approach on the structure for the Clinical Research Center occurred in two areas: Physical Structure and Organizational Structure. The model of administration discussed was based on the analysis of the existent models, identifying the same basis in all of them, including the administrative essential functions for any institution: the planning, organization, command, coordination and control. We customized a model of evaluation of companies, used by the National Quality Foundation in the attainment of the National Prize of Quality, which is used by many leading organizations world-class, adapting it into a model of Quality Management, in which we defined 12 necessary basis for the administration of a Research Center, in order to qualify it to compete in the globalized market of the XXI century, which are: Systemic Thought; Leadership; Vision of the Future; Strategies and Plans: Projection; Adding Value to People: management of competences; Systematic Learning; Culture and Innovation; Direction by Processes and Information; Generation of Value; Knowledge and understanding of the Client and the Market; Development of Partnerships; Social Responsibility.