Clinical Trial Project Management
- 1st Edition - November 14, 2023
- Imprint: Academic Press
- Author: Ashok Kumar Peepliwal
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 1 3 6 2 7 - 6
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 1 3 6 2 8 - 3
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… Read more
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Request a sales quoteClinical 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. The book comprehensively covers the entire clinical trial process of conductance. In addition, the author also incorporates the clinical trial approval processes of USFDA, EMA, and JAPAN for conducting 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
Clinical study Coordinators, Clinical Research Associates (CRA), Clinical Team Leaders (CTL), Clinical Project Managers (CPM), and other Clinical Research Professionals, Courses: MBBS, Bachelor of Science, Bachelor of Pharmacy, Bachelor of nursing, Bachelor of biotechnology, Master of science, Master of Pharmacy, Doctoral Program courses, and Community Medicine courses
1. History of Clinical Trials2. Clinical Research3. Drug Regulatory and its Obligations4. Project Management in Clinical Trials5. Role of Stakeholders6. Clinical Trial Budget Assessment and Preparation7. Clinical Trials: Steps to Conduct8. Clinical Data Management9. Audits and Inspection10. Serious Adverse Event reporting and Compensation11. Randomization, Bias, and Blinding12. Basic Statistical Tools for Clinical Data Analysis13. Advanced Statistical tools for Clinical Data Analysis14. Pharmacovigilance15. Clinical Study Report16. Bioavailability, Bio-equivalence Study Conductance17. Dos, Don’t Dos in clinical trials18. List of CROs19. Question Answers20. References
- Edition: 1
- Published: November 14, 2023
- No. of pages (Paperback): 350
- Imprint: Academic Press
- Language: English
- Paperback ISBN: 9780443136276
- eBook ISBN: 9780443136283
AP
Ashok Kumar Peepliwal
Dr. Ashok Kumar Peepliwal holds a PhD in Pharmaceutical Sciences, Bachelor of Pharmacy, LLB, MBA (Human Resource Management). He has extensive experience in conducting clinical trials and project management: including regulatory dossier submission, protocol approvals, site selection, site initiation, site monitoring, and site close-out etc. He has more than 19 years of experience in the pharmaceutical industry (clinical research) and academics as well. Currently he is working as an associate professor at the School of Pharmaceutical Management, IIHMR University
Affiliations and expertise
Associate Professor, School of Pharmaceutical Management, IIHMR University, Jaipur, Rajasthan, IndiaRead Clinical Trial Project Management on ScienceDirect