Clinical Trials word became a buzz word during this pandemic situation. It played a crucial role in developing vaccine to fight the pandemic.

Experts from different fields contribute to the development of vaccine which includes (not limited) clinical researchers, health care providers, pharmaceutical industry, data managers, biostatisticians, data scientist and clinical trial programmers. Data collection, management, analysis and reporting also play an important role in helping decision makers in approving and rejecting the vaccine.

This book provides an overview of clinical trial management process including protocol development, subject recruitment, professionals and organizations involved in clinical trial, data collection, analysis and reporting. It also covers the models related to Clinical Data Interchange Standards Consortium (CDSIC) standards such as Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).

This book is the second book in the clinical trials series written by the author. Readers are encouraged to refer to the author's book on Essentials of Biostatistics – An overview with the help of Software for biostatistics related contents.

This book is intended for Clinical Trial Managers and clinical research professionals.

Editor IJSMI

International Journal of Statistics and Medical Informatics