Description
Viva Books Gcp and Clinical Research A Managerial Approach 2011 Edition by Umesh C. Gupta
About the Book: GCP and Clinical Research: A Managerial ApproachClinical research in India has grown at an unprecedented rate in the last few years opening many new opportunities. At the same time, especially being a part of global clinical trials, it has put serious challenges for the compliance of trial conduct and validity and integrity of clinical trial data. Towards contributing to the corporate goals of established and emerging CROs and pharmaceutical firms, regarding research, innovation, profitability, and long-term sustainable growth, clinical research domain has become highly regulated and complicated requiring sound knowledge, project management skills and aspirations to achieve compliance with domestic and international regulations as well as towards achieving competitive, quality, compliance, cost and time benefits.This book, an a next-generation book, with plenty of tables, figures, and flow charts has been written with a purpose to satisfy the above unmet need and provides a quality pathway for conducting clinical trials.ContentsChapter 1: Introduction to Clinical ResearchChapter 2: ICH-GCP versus Indian GCPChapter 3: Clinical Trial FrameworkChapter 4: Miscellaneous Topics in Conduct of ClinicalChapter 5: Quality, Compliance and Management IssuesAbout the Author: Umesh C. GuptaUmesh C. Gupta has rich experience in clinical research, has worked in various areas of clinical research including planning, designing, managing, conduct, monitoring and reporting of clinical trials. He has been a teaching faculty for various diploma level courses in clinical trials. he has been a teaching faculty for various diploma level courses in clinical research and has sound knowledge of new drug clinical development and clinical research regulations. Besides holding a lifetime membership of Indian Society of Clinical Research, he has many publications to his credit in various peer-reviewed journals.