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. 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.
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, Dont Dos in clinical trials18.
List of CROs19. Question Answers20. References
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
