Clinical Trial Project Management
eBook - ePub

Clinical Trial Project Management

  1. 350 pages
  2. English
  3. ePUB (mobile friendly)
  4. Only available on web
eBook - ePub

Clinical Trial Project Management

Book details
Table of contents
Citations

About This Book

Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials.

  • Covers how to conduct clinical trials in detail
  • Present useful, basic, and advanced statistical tools
  • Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book

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Yes, you can access Clinical Trial Project Management by Ashok Kumar Peepliwal in PDF and/or ePUB format, as well as other popular books in Business & Pharmaceutical, Biotechnology & Healthcare Industry. We have over one million books available in our catalogue for you to explore.

Information

Publisher
Academic Press
Year
2023
ISBN
9780443136283
Topic
Business
Subtopic
Pharmaceutical, Biotechnology & Healthcare Industry
Index
Business

Table of contents

  1. Cover image
  2. Title page
  3. Table of Contents
  4. Copyright
  5. Foreword
  6. Preface
  7. Acknowledgments
  8. Chapter 1. Historical development of clinical research
  9. Chapter 2. Clinical research
  10. Chapter 3. Clinical trial approval in world
  11. Chapter 4. Project management in clinical trials
  12. Chapter 5. Role of stakeholders
  13. Chapter 6. Clinical trial budget assessment and preparation
  14. Chapter 7. Steps to conduct clinical trials
  15. Chapter 8. Clinical data management
  16. Chapter 9. Audits and inspection
  17. Chapter 10. Serious adverse event reporting and compensation
  18. Chapter 11. Randomization, bias, and blinding
  19. Chapter 12. Basic statistical tools for clinical data analysis
  20. Chapter 13. Advanced statistical tools for clinical data analysis
  21. Chapter 14. Pharmacovigilance
  22. Chapter 15. Clinical study report
  23. Chapter 16. Bioavailability and bioequivalence study
  24. Chapter 17. Risk-based monitoring
  25. Chapter 18. Decentralized clinical trials
  26. Chapter 19. Electronic clinical outcome assessment and electronic patient-reported outcome
  27. Chapter 20. Update of ICH-GCP (addendum R2 and R3)
  28. Chapter 21. Frequently asked questions
  29. Index