Clinical studies management : a practical guide to success

A comprehensive desk reference, this book provides an easy-to-read guide to the practical skills and methods required by project managers running clinical studies. The author uses a framework based on seven core themes: goals, budgets, time, resources, measurement, communication and training to present a solid review of how modern management theory can be brought to bear on the specialist demands of clinical trials. Coverage includes the R & D process, CROs, the Clinical Study Team, and QA audits. The book includes true-life case histories as well as a comprehensive overview of drug development.
Content: Drug Development and Industry Trends --
Contract Research Organizations (CROs) --
The Role of the Clinical Study Project Manager --
Goals and Standards --
Budgets --
Time --
Resources --
Measurement --
Communications --
Training --
Surviving Quality Assurance Audits --
Troubleshooting: A Case History --
Conclusions.
Abstract: A comprehensive desk reference, this book provides an easy-to-read guide to the practical skills and methods required by project managers running clinical studies. The author uses a framework based on seven core themes: goals, budgets, time, resources, measurement, communication and training to present a solid review of how modern management theory can be brought to bear on the specialist demands of clinical trials. Coverage includes the R & D process, CROs, the Clinical Study Team, and QA audits. The book includes true-life case histories as well as a comprehensive overview of drug development