Clinical Research: Principles and Practice is a clear and practical guide to understanding clinical research from core concepts to real-world application. Written for students and professionals, this book explains not only what is done in clinical research, but why each step is essential for patient safety, data integrity, and regulatory compliance.
The content is presented in a logical, step-by-step manner, making complex topics easy to understand and remember. High-quality illustrations and diagrams help simplify trial design, documentation, monitoring, data management, and regulatory processes, allowing readers to grasp concepts quickly and confidently.
The book covers the complete clinical research lifecycle, including trial organization, ethical and regulatory requirements, roles and responsibilities, investigational product management, documentation systems, monitoring, quality assurance, audits, and clinical data management. Strong emphasis is placed on practical understanding alongside academic foundations.
Who This Book Is For
M.Pharm (Pharmacology), Pharm.D, and B.Pharm students preparing for university exams, viva voce, and competitive assessments
Medical students and clinicians seeking a clear understanding of clinical trial processes and regulatory responsibilities
Pharmaceutical industry professionals working in clinical research, regulatory affairs, pharmacovigilance, and quality assurance
CRO professionals, study coordinators, and monitors
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Dr. Nishat Fatima, Dr. Syed Ahmed Iizhar
Dr. Nishat Fatima is the Principal and Professor at Dr. V.R.K. Institute of Pharmaceutical Sciences, Hyderabad, with 20 years of experience. She served as Vice-Principal at Shadan Women’s college of Pharmacy , Khairatabad, Hyderabad, Telangana. Dr. Fatima has published 30 research papers in pharmacology, with over 4,255 reads and 320 citations, contributing significantly to pharmaceutical education and research
Dr. Syed Ahmed Iizhar is a Professor at Sultan ul-Uloom College of Pharmacy, Hyderabad, with 19years of experience. He has published 36 research papers, guided 35 M.Pharm and 14 Pharm.D projects, and holds one patent. Dr. Iizhar has presented 40 papers at international conferences and is a life member of APTI, IPA, IPGA, IPGST, and In Pharma Association.
