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Case Study: Cmed’s Mobile Data Management Solution

The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers.

The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
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