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Over the past ten years, clinical trials on the pharmacological management of sleep disorders have expanded dramatically, both in terms of the number of trials as well as the scope and nature of the trials. In addition to acute and chronic insomnia, studies have been initiated on specific sleep disorders, including sleep related breathing disorders, narcolepsy, circadian rhythm disorders, restless legs syndrome, and nocturia. In addition, studies on the treatment of insomnia in associated psychiatric and medical conditions have become more prominent. These trials evaluate not only sleep-related issues but the course of the comorbid disorders as well. Finally, studies in special populations (pediatrics and the elderly) have become more important in drug registration.
Full Service Clinical Development: Best Practice has been intimately involved in working with corporate sponsors in the development of insomnia drugs from proof of concept to NDA approval. We have helped to guide full development plans and individual protocols for clients, and have designed and overseen the execution of a broad range of trials, including small pilot studies, large-scale phase III trials, and phase IV post-marketing surveillance trials.
Abuse Liability and Drug Scheduling: Companies developing sleep medications carry additional responsibilities due to the potential for abuse of most classes of hypnotic agents. We have assisted clients address drug scheduling and abuse liability questions through preclinical and clinical protocol design and post-marketing studies.
Sleep Site Identification and Certification: Best Practice has developed a network of sleep sites, and tracks the number and types of trials conducted and their success in patient accrual. This is a critical resource given the increased number of trials in the sleep area.
Polysomnographic (PSG) Scoring: Through a network of sleep centers, Best Practice provides scoring, screening and analysis of PSG recordings. This includes sleep wake scoring, sleep stage scoring as well as the scoring of patholological events in sleep.
Sleep Diary Data Collection: Best Practice provides Sleep Diary Data Collection utilizing Interactive Voice Response (IVR).
Click here to view our complete information on Assessment for Sleep Studies
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