Clinical research forms the backbone of modern evidence-based medicine and is an essential area of learning for aspiring healthcare professionals. With the rapid advancements in drug development, regulatory science, and patient-centered care, it is crucial for Pharm D students to gain a solid foundation in the principles and practices of clinical research.
Textbook of Clinical Research has been meticulously prepared to cater to the academic needs of Pharm D 5th year students, following the syllabus recommended by the Pharmacy Council of India (PCI) and leading universities. This book presents complex topics in a simplified, structured, and student-friendly manner, ensuring clarity and conceptual understanding.
The content encompasses key areas such as clinical trial phases, regulatory requirements, ethical considerations, study designs, biostatistics, data management, pharmacovigilance, and Good Clinical Practice (GCP) guidelines. Special emphasis has been given to real-world examples, recent updates, and practical insights to help students bridge the gap between theory and application.
We hope that this textbook serves not only as a guide for academic success but also as a stepping stone for those aspiring to pursue a career in clinical research, regulatory affairs, or the pharmaceutical industry.
 
Dr. P. Thilagesh
Ms. N. Vinodhini
Dr. T. S. Thirugnanam
Dr. Aiswarya Nair U