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Written by renowned expert Ashok Kumar Peepliwal, this book provides a detailed overview of the entire clinical trial process, from start to finish, in an international context.
Conducting clinical trials across nations requires navigating complex regulatory regimes developed by respective regulatory agencies. This book delves into the clinical study protocol approval processes, Ethics Committee approval processes, and clinical study feasibilities, ensuring you have a thorough understanding of the regulatory landscape.
This comprehensive guide covers every stage of the clinical trial process, including:
The book also covers the clinical trial approval processes of major regulatory bodies, including the USFDA, EMA, and Japan, providing you with a deeper understanding of the variations in international regulations.
To manage complex clinical trial projects, the book introduces real-time project management methods, such as Program Evaluation Review Technique (PERT) and Critical Path Method (CPM). These tools will help you streamline your clinical trial management and ensure successful project delivery.
With its comprehensive coverage of clinical trial project management, this book is an indispensable resource for anyone involved in conducting international clinical studies.
Book Details:
Publisher: Elsevier Science
Publication Date: November 15, 2023
Language: English
ISBN: 9780443136276, 9780443136283
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