Project Management for Clinical Trials, 2E, 2003

"The plan is useless, but planning is essential." --Dwight D. Eisenhower. "I need to see your useless plans in order to know you have been planning." --Zi-Ping Fang, Manager.

Project management falls into five broad phases, whether the project is to conduct a clinical trial, throw a birthday party, or go to the moon:

1. Concept
2. Planning
3. Implementation
4. Maintenance
5. Close-out

But embedded within those phases are a myriad of details, starting with Gantt charts and budgets through cost-analysis, metric tracking, site and study maintenance, and close-out issues.  

Most device companies, small or large, don't apply their project management skills to clinical trials; then they are surprised that six months passes before before the first subject is enrolled, or when as much as 60% of the study budget is spent before the first subject is enrolled, or or that subject recruitment is the rate-limiting step.

I wrote this book at the request of a smart client who recognized that traditional project management skills could be applied to planning a clinical trial, and it would give top management better information for making decisions.

After it's first debut it was clear that clinical research managers needed more than just simple project management, they needed schooling in contract law, managing CROs, and common communication problems. The second edition addresses all these issues.