Abstract
Success in the pharmaceutical industry is dependent on many factors. Among them, the efficient management of clinical data is increasingly important. Glaxo Group Research (GGR), to accelerate the preparation of international registration dossiers (IRDs), has devolved the data management of international multicenter studies to the local operating companies (LOCs). The mother company has set up a standalone package that enables LOCs to process data according to central standards.
The Italian subsidiary was recently involved in international development. This paper attempts to provide an overview of this experience, with special reference to data management activities in the context of international development—the issues encountered, the acquisition of knowledge (methodologies, computer tools), and the advantages of this working method.
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