Foundation of Clinical Research: Principles & Practices is a comprehensive guide tailored for pharmacy, medical, and allied health students who aspire to understand the science, structure, and ethics behind modern clinical research. Designed to simplify complex concepts, this book provides a balanced blend of theory and practical knowledge essential for anyone entering the research and regulatory domain.
The book meticulously explores the fundamentals of clinical trial design, ethical considerations, regulatory requirements, pharmacovigilance, data management, and interpretation of clinical evidence. Each chapter is structured to offer clarity, incorporating real-world examples, case discussions, and illustrations to bridge the gap between academic learning and practical implementation.
With its learner-friendly approach, this text serves as both an academic reference and a practical manual, empowering students and early-career researchers to conduct and evaluate clinical research with confidence and scientific integrity.
Whether you are a Pharm.D., M.Pharm., or medical research scholar, this book will serve as a foundational stepping stone toward mastering the principles of good clinical practice and evidence-based medicine.
Key Features of the Book
- Comprehensive coverage of core principles of clinical research as per academic and regulatory frameworks.
- Clear explanation of clinical trial phases, study design, ethics, and regulatory submissions.
- Dedicated sections on pharmacovigilance, data handling, biostatistics, and evidence interpretation.
- Integrates practical examples, case studies, and real-world research insights.
- Ideal for Pharm.D., M.Pharm., medical, and allied health students, as well as early-career researchers and professionals in clinical research organizations (CROs).
About the Authors
Dr. Yogendra Shrestha, Pharm.D., Ph.D., serves as an Associate Professor in the Department of Pharmacy Practice at School of Pharmacy, Parul University, Vadodara, Gujarat. With extensive expertise in pharmacotherapeutics, pharmacovigilance, and clinical research, he has guided several student projects and published over 20 indexed papers. He received the ICMR Senior Research Fellowship in 2022 for his contributions to pharmacoepidemiology and vaccine surveillance.
Dr. Rajesh V., M.Pharm., Ph.D., is the Professor and Head of the Department of Pharmacy Practice at Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G. Nagara. With vast experience leading clinical trial operations and mentoring Ph.D. scholars, he has authored over 45 indexed publications and secured multiple research grants, contributing significantly to academic and clinical research advancement.
Book Information
- Publisher: ShivKesh Publication
- Address: Gurash Chowk, Gauradaha–3, Jhapa, Nepal–57216
- Format: Paperback | English
- ISBN: 9789937163552
- Target Audience: Pharm.D., M.Pharm., B.Pharm., medical, and health science students; academic researchers; CRO professionals.
📧 Email: shivkeshpublication@gmail.com | info@shivkeshpublication
📞 Phone: +91 7348944358
