Clinical Trial Management: Indian clinical trial regulations and clinical trials management methods (Paperback)
India is playing a very important role by providing cost-effective solutions for the drug development and clinical research industries. Almost every major city and suburban second-tier cities are hosting a lot of companies, contractors, and subcontractors to support the pharmaceutical, nutraceutical, and AYUSH product development activities. Rules and regulations evolved significantly in the past two decades, and various activities of clinical research, ethics in clinical research, and CRO/SMO functions were brought under the Indian legal framework. Continuous efforts are made to communicate the same through various workshops, conferences, and one-on-one deliberations. Every meeting tried to address the need for the latest information but could not complete the information delivery in a comprehensive and complete manner. We at the Medical Pharmacologists Society felt the need of the hour and organised a programme to deliver the required information through the MPS NCTS 2023 online conference held on August 5-6, 2023-a 2-day conference. Since the topics chosen were important and very relevant to the needs of clinical research organisations (CROs, SMOs, KPOs, etc.) and pharmaceutical industries, we encouraged all the speakers to write a chapter on their topic and submit it to us. Finally, we were able to complete it successfully and release it during the conference. Now the title of this book is very much registered among the attendees (430 plus), and they are requesting a hard-bound copy for their day-to-day reference. We believe no other book is currently available to cover all the topics discussed in the conference, and no other one-stop source of proper information is currently available.
This book is needed for all kinds of staff and postgraduates, irrespective of stream: medical subjects, pharmaceutical subjects, AYUSH subjects, biotechnology subjects, etc. In addition, this book is needed as a ready reference for experts working in clinical research, drug development, pharmaceutical development, ayurvedic (AYUSH) product development, biological and biotechnological product development, and, to some extent, medical device development industries. Throughout the globe, people are interested in releasing products in India and other countries and may need some ready reference to understand the regulations in India. In such a situation, they are finding it difficult to find a suitable source of the latest information. Therefore, this book is required for staff working for international companies that are looking to launch drug products in India. The readers of this book can go beyond the geographical boundaries and their area of study.