Clinical Studies Management: A Practical Guide to Success

ISBN-13: 9780849320842 / Angielski / Twarda / 2004 / 128 str.

Simon Cook

Opis

Covers the principles of Good Clinical Practice Guidelines Contains case histories that illustrate successes and discusses how to get a project back on track Integrates R&D into the clinical study sequence and models how to write a study protocol Offers anecdotal and visual examples with easy-to-remember reference points Presents a comprehensive overview of the drug development process and the trends that are driving change Includes analysis of interactions between sponsors and CROs and a profile of the ideal project manager 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 ef

Recenzje

"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

Spis treści

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

O autorze

Simon Cook