Riquelme AI, Álvarez GS, González HZ, Saborido ML

Language: Spanish
References: 6
Page: 582-587
PDF size: 91.38 Kb.

ABSTRACT

Introduction: the National Coordinating Center of Clinical Assays (CENCEC in Spanish) has the fundamental function of performing clinical assays in new products from the Cuban biotechnological and drug industry. Since 2008, the Center has the quality management system in place to continuously improve its processes. A key factor for good development and assurance of the results of its research is the work of the clinical sites.
Objective: to find out the main difficulties in the monitoring of the clinical sites.
Methods: the evaluation of the work quality of the clinical sites in the first semester of 2011 took into consideration the fulfillment or non-fulfillment of the requirements set in the Good Clinical Practice Guide for the clinical research.
Results: the main difficulties are found in the sections of the institutions, in the requirements for necessary resources, in issues linked to the institutional ethics committee and in qualifications and agreements with the researcher; these are aspects having an impact on the fulfillment of Good Clinical Practices by the clinical sites, which also affects the quality of service rendered by CENCEC.
Conclusions: this paper may serve as a starting point for ongoing improvement of the quality management system of the organization in order to direct our efforts to the total implementation of the principle of mutually beneficial relationships with the suppliers.

REFERENCES

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