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Unformatted text preview: estigational sites and clinical data. By the early 1990s, drug development became a globalized endeavor, in part, under the aegis of the International Conference on Harmonisation, or ICH (in which the U.S. FDA played a key developmental role).8 The ICH created international standards for ensuring and assessing the safety and quality of testing procedures for experimental compounds, including Good Clinical Practice guidelines for investigators and the implementation of IRBs. Most importantly, it eased the acceptability and transference of clinical data from foreign investigational sites to the FDA for regulatory approval of new drugs.9 Today, CROs are highly competitive transnational businesses that run clinical trials for pharmaceutical, biotechnology, and medical device industries. They offer expertise in submissions of clinical trial data to regulatory bodies and in conducting market analyses of existing and prospective drugs. Their main source of revenue comes from conducting clinical trials in an efficient and costeffective manner, particularly the second and third phases 185...
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This note was uploaded on 10/10/2010 for the course ENG 000121 taught by Professor Mcgrand during the Spring '10 term at Cornell.
- Spring '10