Guide to planning and managing multiple clinical studies

By Bert Spilker

Book Overview

No Synopsis Available.

• Format: Paperback
• Language: English
• ISBN: 0881672645
• ISBN13: 9780881672640
• Release Date: January 1987
• Publisher: Raven Press
• Length: 410 Pages
• Weight: 1.95 lbs.

Customer Reviews

Good reference for Start-up Companies

Working in a small biotech start-up company, I think this book is a great reference especially if you have limited resources and interested in conducting drug development the "right" way. This text covers all areas of drug development and useful for people in regulatory affairs, project management, clinical affairs, and data management.

This text is the industry standard.

If you could only have one book on clinical research, this should be the one. It is comprehensive, and presents much of the material in tabular format that greatly facilitates learning. I have been in the drug development business for over 30 years and still refer to this text on a regular basis.

The best guideline book on the subject.

A basic handbook for management of clinical trials. This is a "must" reading for anyone who deals with clinical trials. It covers areas of protocol development, regulatory issues in human clinical trials. There is a detailed section on data collection, handling data and statistical issues.Also an introduction to project management.The book contains a large amount of tables easy to read and with great "tips".