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Disseminating quality controlled scientific knowledge

1. Exceeding expectations in time, quality and economy by choosing the right clinical research solution

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Author(s): David M. Shearer

Journal: International Journal of Pharmaceutical and Biomedical Research (IJPBR)
ISSN 0976-0350

Volume: 02;
Issue: 01;
Start page: 1;
Date: 2011;
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Keywords: Clinical research organization | Phase I –IV clinical trials | Protocol design | Decision making | Six sigma

ABSTRACT
Factors which contribute to the ultimate success or failure of Phase I-IV clinical trials involve complexities such as clinical operations, medical affairs, data management and stringent timelines which potentiate interference with the quality and integrity of a trial. Upon completion of a study, the sponsor may reflect upon the research experience and philosophize as to how it might have been different and how to change future decision-making strategies. The approval of a medication or device is at crucial risk of being delayed or denied by regulatory authorities if proper study approaches are not addressed. A process exists to adequately assess experience, flexibility, electronic capabilities and compliance when choosing an appropriate research solution. The intent of this document is to add clarification as to the factors within this process, which should be considered in order to maximize efficiency, productivity, communication and results while minimizing costs and unnecessary errors.

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