"It was a wonderful experience interacting with you and appreciate the way you have planned and executed the whole publication process within the agreed timelines.”
Subrat SaurabhAuthor of Kuch Woh Pal
COMPREHENSIVE GUIDE TO CLINICAL RESEARCH REGULATIONS:
THEORY AND PRACTICE
This 25-chapter exhaustive resource dives deep into the essential topics of clinical research and regulatory compliance.
Comprehensive Guide to Clinical Research Regulations: Theory and Practice is designed to simplify complex subjects, making them accessible to professionals, students, and researchers alike. Covering every phase of clinical trials, from Phase 0 to Phase IV, this book navigates critical areas such as Good Clinical Practice (GCP), informed consent, and regulatory submissions.
Key Features Include:
25 detailed chapters that provide step-by-step guidance on regulatory frameworks and global standards for clinical research.
A wealth of illustrations and visual aids to make complex concepts easier to understand.
Extensive coverage of the FDA, EMA, CDSCO, and their regulations, along with case studies demonstrating real-world applications.
Clear and concise explanations of difficult topics, making even the most intricate aspects of clinical research manageable.
This guide is the perfect blend of theory and practice, with each chapter offering practical insights into navigating the often-complicated world of clinical research regulations. Whether you are preparing for clinical trials, managing drug development, or studying for professional growth, this book ensures you have everything you need in one comprehensive reference.
Dr. C. Ronald Darwin, Dr. Praful J Kumar, Dr. A. R. Vijayakumar
Dr. Ronald Darwin C is a distinguished Professor and Head of the Department of Pharmacology at the School of Pharmaceutical Sciences, VISTAS. Dr. Darwin holds a Ph.D. in Pharmacology from The Tamil Nadu Dr. MGR Medical University, Guindy, Chennai, where he also completed his M.Pharm and B.Pharm degrees.His expertise in animal study design and neuropharmacology research has been widely recognized and has led to the publication of 32chigh-impact research articles, the highest of which boasts an impact factor of 15.8. Additionally, his inventive prowess is demonstrated by his 9 patents and substantial contributions to textbook and chapter writing, including seven textbooks
Dr. A. R. Vijayakumar, M.Pharm., Ph.D., FASc., serves as Professor and Head of the Department of Pharmacology at the Faculty of Pharmacy, Sree Balaji Medical College and Hospital, part of the Bharath Institute of Higher Education and Research (BIHER), Chromepet, Chennai, Tamil Nadu, India.
Dr. Vijayakumar embarked on his illustrious educational journey at The Tamil Nadu Dr. M. G. R. Medical University, Chennai, where he completed his Bachelor’s degree in Pharmacy in 2003 and his Master’s Degree in Pharmacology in 2005. He earned his Ph.D. in Medical Sciences from 2008 to 2013 at Dr. RPC, All India Institute of Medical Sciences (AIIMS), New Delhi.With over 34 publications in esteemed PubMed, Scopus, and Web of Science indexed journals, and around 9 book chapters to his name, Dr. Vijayakumar is a respected reviewer for numerous national and international scientific journals.
Dr. Praful J Kumar's illustrious career began as Team Leader at Tamilnadu's Govt's pioneering Emergency Care Centre. Leveraging his exceptional clinical expertise and acumen, he successfully treated critically ill, trauma, medical, and surgical emergencies, saving countless lives. Notably, several of his challenging and intersting cases have been published in esteemed magazines and journals.
Committed to serving the underserved, Dr. Praful joined a Rural Primary Health Care Centre as Medical Officer. He conducted numerous medical camps, blood donation drives, school health initiatives, vaccination programs, and community outreach activities.Currently, Dr. Praful is pursuing his postgraduate studies at Chennai's prestigious Govt. Stanley Medical College. His passions include teaching and mentoring fellow medical professionalls, clinical innovation, sharing expertise through knowledge dissemination.
