Clinical Studies Management: A Practical Guide to Success

Simon Cook9780849320842, 0849320844

In this survival guide for project managers running clinical studies, Cook, an independent consultant in the UK, outlines a framework for project management based on seven core themes: goals, budgets, time, resources, measurement, communication, and training. He overviews the drug development process and trends that are driving change, then looks at how modern management theory can be brought to bear on the specialized demands of clinical trials. Covering practical aspects of writing and costing a study, organizing an investigator meeting, and improving patient enrollment in a study, the book offers good practice guidelines, case histories, and anecdotal and visual examples to aid in remembering key points.