This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting.

Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct...

Compliance requirements are here to stay.

Prepare your company for the growing challenge.

A Wall Street Journal/Harris poll revealed that two thirds of investors express doubts in the ability of corporate boards of directors to provide effective oversight. In the shadow of recent global scandals involving businesses such as Parmalat and WorldCom, Manager's Guide to Compliance: Best Practices and Case Studies is essential reading for you, whether your organization is a major corporation or a small business.

This timely handbook places U.S. and global regulatory information, as well as...