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An Overview of Clinical Trial Operation Fundamentals of clinical trial planning and management in drug development

by Shibadas Biswal, Vinu M Jose

ISBN9789384049447

Type : Paperback

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Overview

Summary of the Book

At the moment, human experimentation (i.e. clinical trial) is still the most relevant method at our disposal to explore and establish safety/efficacy of a new medicine. It is the fundamental basis of clinical development programs of healthcare products. With socioeconomic development in the asia-pacific region, there is a shift in focus at a global level in many areas including healthcare sector. Many organizations have already made significant investments to tap the potential, and regulatory environment is shaping up to facilitate clinical research. This is a welcome change for both patients and professionals.

Clinical research has opened up several new career choices. Graduates in medicine, pharmacy and other life sciences now have the option to work as investigators, scientists, project managers, data managers, monitors, study coordinators, regulatory affairs managers, and so on. Many of these positions have specialized and focused responsibilities in the industry setting. Considering the highly complex environment of clinical research, an understanding of the big picture is indispensable for effective collaboration.

This book is a must read for students and professionals for a broad understanding of the entire process of clinical trial operation.

About the Author

Shibadas Biswal is a medical doctor with specialization in pharmacology from the PGIMER, Chandigarh, India. Currently he works in the pharmaceutical industry in the field of clinical research. He has worked with major Indian and multinational pharmaceutical companies.

Vinu M Jose is a medical doctor with specialization in pharmacology from the CMC, Vellore, India and super specialization in clinical pharmacology from the PGIMER, Chandigarh, India. He currently works in the pharmaceutical industry in the domain of clinical research. He has been associated with major Indian and multinational pharmaceutical companies. In the past, he has held faculty position in pharmacology.

Both the authors bring over 20 years of collective experience in planning and conducting clinical trials in both academic and pharmaceutical industry in various phases of drug development in several major countries across the globe.


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