Comprehensive Clinical Plan Development for a Novel Product to Treat Panic Disorder

Premier Research was contracted to assist a client in creating a comprehensive clinical development plan for a novel product to treat Panic Disorder. The sponsor sought to characterize the medical need and the potential market for the product, determine the most efficient path to market (including the evaluation of potential indications), evaluate risks in development, and determine the clinical trials needed.

Among the critical activities for the SPD group was an extensive literature review for potential indications, a face-to-face meeting with a panel of clinical experts in the therapeutic area, evaluation of study feasibility, and comprehensive costing of proposed studies. The information from the plan was subsequently used by the client to make decisions regarding product investment.

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