Industry sponsors often ask research directors to have their sites participate in clinical research trials: Phase I (first human trials and/or pharmacokinetic evaluation) through Phase IV (post-market evaluation). Industry sponsors need clinical trials in order to advance their drug or device through the FDA process to get it to market or for post-market analysis. Clinical trials are very expensive to industry sponsors ; therefore, they must identify potential clinical research trial sites that have a high probability of enrolling the necessary number of subjects .
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Mitigating Administrative Risks in Industry-sponsored Clinical Trials – Corrected Proof