Clinical Trial Project Management

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

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