A Practical Guide to Quality Management in Clinical Trial Research
Examining how to maintain assured quality in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides solid foundations, tips, and techniques for establishing a quality system that will comply with the relevant regulations. This book offers useful information for various standards including Good Laboratory Practice, Good Clinical Practice, and Good Manufacturing Practice. It gives detailed explanations of how to prepare, update, and maintain Standard Operating Procedures and also includes advice on training and development of personnel. This text is ideal for clinical trial monitors and quality assurance personnel in the pharmaceutical industry.
"?provides the reader with a pragmatic approach to the principles governing accepted methodologies within the working environment and provides some useful examples of these interpretational differences across industry."-Quasar"?provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations."--Anticancer Research