This insight brief examines common barriers that delay clinical study start-up and how functional service provider (FSP) models can help overcome them. It contrasts challenges faced by life sciences companies managing studies in-house—such as limited resources, fragmented processes, and regulatory complexity—with those encountered in fully outsourced models, including reduced visibility and lack of flexibility. The brief identifies critical areas requiring expert partner support, including regulatory submissions, site activation, contracts, and start-up governance. It explains the role of FSPs in providing specialized expertise, scalable resourcing, and operational consistency. IQVIA’s customizable FSP start-up model is highlighted as a flexible, hybrid approach designed to address bottlen

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