CASE STUDY Sophisticated clinical trials for challenging therapeutic areas At a time when clinical trials are becoming more and more complex – due in no small part to increased regulatory requirements – phase III trials are especially complicated, with few drugs (approximately one-third) proceeding from phase II. In such an environment, an organization seeking to conduct a trial for a rare and complicated disease state, such as life- altering central nervous system (CNS) disorders, already faces an inordinate challenge. Add further complications such as managing a small patient population, running the trial within urgent or emergency-type settings, like a hospital intensive care unit (ICU), and the difficulty-level increases manifold. Such a case would require partnership with

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