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As a busy research professional, perhaps you opened this book looking for ways to grow your clinical research enterprise. You feel confident about your clinical knowledge and experience, have a good understanding of research theory, and may already be involved in conducting several clinical trials. But when it comes to managing the business side of clinical trials—strategic planning, calculating operating margins and break-even points, and managing resources—your confidence level may dip.

An understanding of how to manage a portfolio of clinical trials and run a research enterprise is not easy to come by. Publications may have scattered comments here and there. For some fortunate people, a mentor may be available to help them through this management process. Typically, however, the administrative, financial, and quality-improvement aspects of performing clinical trials is typically acquired through experience—and often a lot of trial and error.

This chapter introduces some of the fundamental business administration processes associated with clinical trials, and research professionals can easily adapt these for their use. Treating a research enterprise like a small business endeavor—because that is essentially what it is—can make planning, finance, and resource management more effective and efficient.


Experienced research professionals with expert clinical skills may have limited or no experience with managing the business aspects of their portfolio of studies. Activities related to business administration such as creating strategic plans, calculating operating budgets, and managing research human resources are the behind-the-scenes details that are necessary to keep a research enterprise running.

Creating the business infrastructure for your research enterprise begins with some very practical questions:

  • I need to figure out ways to successfully grow my research enterprise. Can a strategic plan help me?

  • Do research finance accounts require specialty knowledge to manage? How much of a time commitment will this take? Do I need an accountant to track revenue and expenses and reconcile payments from the sponsor?

  • What is a reasonable amount of time to expect our research enterprise to break even?

  • What types of research staff are needed to work on trials? How many people do I need to hire?

  • How can I translate all of the regulatory requirements and guidance into everyday practice?

  • Who is responsible for quality assurance?

Each of the chapters in this book will address these issues by providing tools, examples, and references for where more information can be found. Throughout this book, you will see that our successful approach to answering these questions regarding management of a research enterprise has three fundamental steps:

  1. We learn and, whenever possible, adapt what already exists within our larger organization for use in our operations.

  2. We continually assess risk: the risks of what we are doing and how we are currently doing things against the risks of introducing change; hiring, adopting new systems, ...

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