Clinical Trial Project Management: A Comprehensive Guide

Written by Ashok Kumar Peepliwal, this book provides a detailed overview of conducting clinical trials in an international context. The process of conducting clinical studies across nations is governed by a set of regulatory regimes developed by respective regulatory agencies.

Regulatory Frameworks and Approvals

The book delves into the intricacies of clinical study protocol approval processes, Ethics Committee approval processes, and clinical study feasibilities. It also covers site selection, site initiation, site monitoring, database lock, site close-out, clinical data processing and management, SAE reporting and compensation, and randomization procedures.

Country-Specific Regulatory Approaches

In addition to providing a general framework, the book also explores the clinical trial approval process of prominent regulatory agencies such as the USFDA, EMA, and Japan, offering valuable insights into conducting clinical trials in these regions.

Statistical Tools and Project Management

The author presents a range of useful, basic, and advanced statistical tools, as well as real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects.

Comprehensive Coverage of Clinical Trials

This comprehensive guide covers the entire clinical trial process, from protocol approval to clinical study report writing. It provides a detailed understanding of pharmacovigilance, BA/BE studies, and clinical data processing and management.

With its in-depth coverage and practical approach, this book is an invaluable resource for professionals involved in clinical trial project management.

Publisher: Elsevier Science

Publication Date: November 15, 2023

Language: English

ISBN: 9780443136276, 9780443136283