Clinical studies management : a practical guide to success / Simon Cook.

Format:

Book

Author/Creator:

Cook, Simon, 1959-

Language:

English

Subjects (All):

Drugs--Testing.

Drugs.

Clinical trials.

Drug Evaluation.

Clinical Trials as Topic.

Practice Management--organization & administration.

Medical Subjects:

Drug Evaluation.

Clinical Trials as Topic.

Practice Management--organization & administration.

Physical Description:

108 pages : illustrations ; 24 cm

Place of Publication:

Boca Raton : Interpharm/CRC : Sue Horwood Pub., [2004]

Summary:

What if you were suddenly in charge? After the initial excitement of a "battlefield promotion" wears off, you need to get in the trenches and get the job done. And if you are already in the trenches, you need quick access to information that will make your job easier. A comprehensive desk reference and guide, Clinical Studies Management: A Practical Guide to Success provides the practical skills and methods required by project managers running clinical studies. The author explains a framework for project management based on seven core themes: goals, budgets, time, resources, measurement, communication, and training. He solidly reviews how modern management theory can be brought to bear on the specialized demands of clinical trials. The book covers the practical how-tos of writing and costing a study, organizing an Investigator Meeting, and improving patient enrollment in your study. Divided into stand-alone chapters that make the information easy to find, the book presents a comprehensive overview of drug development processes and the trends that are driving change. If you are new to study management, the book rapidly brings you up to speed. If you are an experienced study manager, it gives you a convenient and authoritative reference you will use on a daily basis. Whatever your level of experience, Clinical Studies Management: A Practical Guide to Success supplies the tools you need to manage your projects efficiently and effectively.

Contents:

1. Drug Development and Industry Trends 1

2. Contract Research Organizations (CROs) 19

3. The Role of the Clinical Study Project Manager 25

4. Goals and Standards 35

5. Budgets 47

6. Time 55

8. Measurement 67

9. Communications 71

10. Training 79

11. Surviving Quality Assurance Audits 87

12. Troubleshooting: A Case History 93.

Notes:

Includes bibliographical references (pages 101-102) and index.

ISBN:

0849320844

OCLC:

53286247