This comprehensive and well-organized text is grounded in real-world applications of theoretical concepts of Clinical Research with a primary focus on Drug development and clinical trial processes, Good Clinical Practices (GCP) guidelines, Drug regulatory affairs, Roles and responsibilities of various clinical trial stakeholders etc. A step by step guide for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, government and legal professions. The text provides exemplary coverage of all the relevant issues. The definitive book on the subject