1st Edition

Clinical Studies Management A Practical Guide to Success

By Simon Cook Copyright 2004
    128 Pages 36 B/W Illustrations
    by CRC Press

    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.

    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

    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