Project Management for Clinical Studies, Second Edition (2003)

Stark NJ, Project Management for Clinical Studies, Clinical Device Group Inc, Chicago, IL (2003), 290 pages. Perfect bound, illustrated, ISBN 1-889160-09-1. $250 US.

Complex to implement and insidious in their propensity for cost overruns and schedule delays, poorly managed clinical trials may postpone marketing applications and result in expensive "lost opportunities". In this book the traditional skills of project management -- conception, planning, implementation, monitoring, and close-out -- are applied to clinical research to help assure smooth implementation and on-time completion. Click for author's notes or to order.

1. The Project Team
2. Defining the Project
3. Claims
4. Project Scheduling
5. Resource Assignments
6. Resource Allocation
7. Project Budgeting
8. Cost Analysis
9. Tracking Projects
Maintaining Projects
11. Project Close-Out
12. The Product Development Cycle
13.Working with CROs
14. Contracts
15. Project Communications