Clinical research is a complex and highly regulated area of medical science, involving a large number of individuals and organisations, including pharmaceutical companies, contract research organisations, and clinical trial centres. This article answers some basic questions about the pharmaceutical and clinical research industries, including drug development in humans, and gives an overview of the ever-changing regulations governing such research.
What is clinical research? Clinical Research is a division of science that assesses the safety and effectiveness of new medications and medical devices in animals (preclinical) and humans (clinical). The term ‘clinical research’ encompasses the entire lifecycle of an investigation product or device, including its discovery and development in the lab (preclinical), through phases I-III of human development, regulatory assessment, and product approval and marketing. Clinical research is a highly regulated, multidisciplinary, global industry, involving large number of highly skilled research professionals.
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