Original price was: $170.00.Current price is: $21.00.

Clinical Trial Project Management (EPUB)

Clinical Trial Project Management: A Comprehensive Guide to Conducting International Clinical Studies

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.

Regulatory Frameworks and Approvals

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.

The Clinical Trial Process: A Step-by-Step Guide

This comprehensive guide covers every stage of the clinical trial process, including:

  • Site selection and initiation
  • Site monitoring and database lock
  • SITE close-out and clinical data processing and management
  • SAE reporting and compensation
  • Randomization procedures
  • Pharmacovigilance and statistical tools
  • BA/BE studies and clinical study report writing

Country-Specific Regulations and Approvals

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.

Effective Project Management Methods

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

Additional information

Language

Author