Developing a World Class Clinical Trial Site

The book is aimed at providing a comprehensive understanding of new drug discovery and development process along with guidance on how to get involved in a clinical trial; constitution of study team at a site; infrastructure development; study initiation, conduct and closeout; safety reporting; informed consent process; investigational product accountability and management; maintenance of source document; completion of case report forms; HIPAA privacy rules; clinical trial monitoring; regulatory inspections etc. The book would be of great benefit to the existing and new investigators/sites.