PART I: PLAN. 1. Cut Costs and Increase Profits. 2. Guidelines. 3. Prescription for Success. 4. Staffing for Success. 5. Design Decisions. 6. Trial Design. 7. Exception Handling. PART 2: DO. 8. Documentation. 9. Recruiting and Retaining Physicians and Patients. 10. Computer-Assisted Data Entry. 11. Data Management. 12. Are You Ready? 13. Monitoring the Trials. 14. Managing the Trials. 15. Data Analysis. PART 3: CHECK. 16. Check. Appendix: Software. Author Index. Subject Index.
"...readable, informative and at times witty...never stops being concise and well written...a book worth a read..." (Statistics in Medicine, Vol 23(3), 15 February 2004) "The book is very prescriptive and full of lists and tables with which to guide managers in making effective decisions in using computer-assisted clinical trials in pharmaceutical studies." (Technometrics, Vol. 45, No. 1, February 2003) "This book is must-have reading for anyone in the business..." (Clinical Chemistry, Vol. 49, No. 7, 2003)
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