COMPREHENSIVE GUIDE TO CLINICAL RESEARCH REGULATIONS:
THEORY AND PRACTICE
This 25-chapte
r 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.