Business Administration for Clinical Trials

Book excerpt: Clinical research administration is much like an orange-remove the peel, and what appears to be simple is actually many interconnected, but separate, sections. Investigators conducting clinical research trials must manage the myriad administrative aspects of the research enterprise. New investigators often underestimate the time commitment and resources that research management requires. Clinical research professionals must manage this complicated process while fostering productive environments and relationships and also navigating regulation, compliance, and the institutional review board. Filled with tools, techniques, and templates, Business Administration for Clinical Trials provides research professionals a road map and deeper understanding of strategic planning, financial management, and regulatory implementation to successfully conduct clinical research trials. Cavalieri and Rupp share their highly practical and easily adaptable tactics for developing an effective administrative infrastructure and designing a study down to the granular level. This book will help you: - Develop business plans - Negotiate study contracts - Navigate regulatory approval processes - Secure resources, testing services, and support - Foster professional relationships - Manage revenue cycles - Put regulations into practice - Implement effective quality-control processes