Clinical Trial Project Management
eBook - ePub

Clinical Trial Project Management

  1. 350 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Clinical Trial Project Management

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.

Table of contents

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