Clinical Trials word became a buzz word during this pandemic situation. It played a crucial role in developing vaccines to fight the pandemic.
Experts from different fields contribute to the development of vaccines which includes (not limited) clinical researchers, health care providers, pharmaceutical industry, data managers, biostatisticians, data scientists 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 processes 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 authors book on Essentials of Biostatistics An overview with the help of Software for biostatistics related contents.