Chapter 1
Introduction and Brief History of the Clinical Research Process
Dr. Mangesh Khadakban is a highly experienced clinical research scientist with expertise in areas such as clinical trials, medical writing, regulatory affairs, and pharmacovigilance. With a successful track record in drug development, he has managed clinical studies globally, including in Russia, Europe, and the USA.
Dr. Khadakban has led large teams, specializing in Phase 0- Phase 4 Trials, clinical development of NCEs, NBEs (Monoclonal Antibodies), Biosimilars, Stem Cell therapies, Nutraceuticals and Ayurvedic Products. He has received multiple honors, including recognition from the Governor of India and the WHO. In addition to his research, he has mentored over 20,000 students across various fields and has patented innovative research.
“From Lab to Life” provides a comprehensive and easy-to-understand guide to the essential steps involved in conducting clinical trials. It covers everything from the initial planning phase, including study design and protocol development, to data collection, analysis and regulatory approval.
The book also emphasizes the importance of patient safety and compliance throughout the trial process. Drawing from his vast experience, Dr. Khadakban explains complex concepts in simple terms, making the book a valuable resource for those looking to gain a deep understanding of clinical trials and their critical role in medical research.
Chapter 1
Introduction and Brief History of the Clinical Research Process
Chapter 2
Drug Development from Molecules to Prescription
Chapter 3
A Brief History of GCP and the Principles
Chapter 4
What is IEC/IRB and What Are Its Roles?