124 Pages
36 B/W Illustrations
by
CRC Press
128 Pages
by
CRC Press
Also available as eBook on:
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... Read more
DRUG DEVELOPMENT AND INDUSTRY TRENDS
From Concept to Market
Industry Trends
CONTRACT RESEARCH ORGANIZATIONS
Outsourcing to CROs
THE ROLE OF THE CLINICAL STUDY PROJECT MANAGER
The Project Team
The Function of the Manager
High-Rise vs Hands-Off
GOALS AND STANDARDS
Objectives and Milestones
Clinical Research Standards
Writing a Study Protocol
BUDGETS
Where the Money Goes
TIME
The Cost of Time
Finding the Critical Path
The Proactive Approach
RESOURCES
Manpower
Drug Supplies
MEASUREMENT
Quality Tracking
Taking the Project Pulse
COMMUNICATIONS
Efficient Signalling
Team Meetings
Presentations
TRAINING
In Pursuit of Error-Free Work
Organizing an Investigators' Meeting
SURVIVING QUALITY ASSURANCE AUDITS
Quality Assurance in Clinical Research
TROUBLESHOOTING: A CASE HISTORY
Introduction
Problems
Prioritising Actions
Recruitment Enhancement
Getting Back on Track
CONCLUSIONS
References
Index
From Concept to Market
Industry Trends
CONTRACT RESEARCH ORGANIZATIONS
Outsourcing to CROs
THE ROLE OF THE CLINICAL STUDY PROJECT MANAGER
The Project Team
The Function of the Manager
High-Rise vs Hands-Off
GOALS AND STANDARDS
Objectives and Milestones
Clinical Research Standards
Writing a Study Protocol
BUDGETS
Where the Money Goes
TIME
The Cost of Time
Finding the Critical Path
The Proactive Approach
RESOURCES
Manpower
Drug Supplies
MEASUREMENT
Quality Tracking
Taking the Project Pulse
COMMUNICATIONS
Efficient Signalling
Team Meetings
Presentations
TRAINING
In Pursuit of Error-Free Work
Organizing an Investigators' Meeting
SURVIVING QUALITY ASSURANCE AUDITS
Quality Assurance in Clinical Research
TROUBLESHOOTING: A CASE HISTORY
Introduction
Problems
Prioritising Actions
Recruitment Enhancement
Getting Back on Track
CONCLUSIONS
References
Index
Biography
Simon Cook
"This book successfully provides an in-depth examination into the daily life of clinical study management in an easy-to-read, easy-to-reference format…a perfect supplement to the mandatory training one would receive in the industry. Those new to research and/or clinical project management will find this book to be essential reading and well-deserving of a place in their office, cubicle, or home library. Four stars!"
- Nicholas Greco IV, MS, Abbott Laboratories, in Doody's Notes, 2004
