Chapter 10. Clinical Trials and Project Management

  1. Scott D. Babler
  1. Scott E. Smith1,
  2. Carol A. Connell2 and
  3. Dirk L. Raemdonck3

Published Online: 29 JUL 2010

DOI: 10.1002/9780470636930.ch10

Pharmaceutical and Biomedical Project Management in a Changing Global Environment

Pharmaceutical and Biomedical Project Management in a Changing Global Environment

How to Cite

Smith, S. E., Connell, C. A. and Raemdonck, D. L. (2010) Clinical Trials and Project Management, in Pharmaceutical and Biomedical Project Management in a Changing Global Environment (ed S. D. Babler), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470636930.ch10

Editor Information

  1. Integrated Project Management Company, Inc., USA

Author Information

  1. 1

    Pfizer Inc., New York, NY, USA

  2. 2

    Clinical Development & Medical Affairs, Specialty Care, Pfizer Inc., New London, CT, USA

  3. 3

    Medical Development Group, Emerging Markets Business, Pfizer Inc., New York, NY, USA

Publication History

  1. Published Online: 29 JUL 2010
  2. Published Print: 7 SEP 2010

Book Series:

  1. Wiley Series on Technologies for the Pharmaceutical Industry

Book Series Editors:

  1. Sean Ekins

ISBN Information

Print ISBN: 9780470293416

Online ISBN: 9780470636930

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Keywords:

  • clinical trials and project management - managing unique project complexities;
  • “investigational products” and Good Manufacturing Practices (GMP), strict and detailed guidelines governing preparation, labeling, shipping and storing;
  • project management skills - for delivering project goals, planning, initiation, completion and reporting of clinical studies

Summary

This chapter contains sections titled:

  • Anatomy of a Clinical Study

  • Special Aspects of Project Managing Clinical Studies

  • Best Practices for the Clinical Study Project Manager

  • Special Considerations

  • Additional Resources for Chapter 10