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Clinical Research Data Quality Standardization in an International Environment

  • Clinical Research is expanding into an international and more regulated environment, specifically its quality management. Pharmaceuticals and Research Organizations are investing significant amounts of money as well as the regulatory agencies. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are improving and developing regulations and meetings to standardize globally these practices. Therefore this Thesis integrates and extends the FDA and EMA recommendation of implementing “Risk based quality management” in Clinical Research protocol execution with a multisource point of view and the proposal of adding a Risk Management Report as an output, which will work also as an input for future protocols implementation. Diverse articles and regulations related with Quality Management and Clinical Research Processes were reviewed to work as a base for the analysis of this thesis. Risk Based Quality Management is the actual trend and newly implemented process to improve quality in clinical research. The goal of this Thesis is to combine the different actual factors, methods and regulations in order to expand Risk Based Quality Management and reach a better degree in quality and standardization. The question therefore is whether this redesigned Risk Based Quality Management process can really be incorporated with the actual practices, and if it is possible to adopt it in Clinical Research.

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Author:Fabiola Vanessa Aldana
Advisor:Christoph Mergard
Document Type:Master's Thesis
Year of Completion:2015
Year of first Publication:2015
Release Date:2015/11/26
Degree Program:MBA - International Business Management