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Clinical Studies Management

A Practical Guide to Success

By Simon Cook

CRC Press – 2004 – 128 pages

Purchasing Options:

  • Add to CartHardback: $119.95
    978-0-8493-2084-2
    January 15th 2004

Description

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.

Reviews

"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

Contents

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

Name: Clinical Studies Management: A Practical Guide to Success (Hardback)CRC Press 
Description: By Simon Cook. 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...
Categories: Clinical Implementation, Analysis & Pharmaceutical Quality, Healthcare Management