Ashok Kumar Peepliwal

Clinical Trial Project Management (eBook, ePUB)

• Format: ePub

Produktbeschreibung

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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Produktdetails

• Verlag: Elsevier Science & Techn.
• Seitenzahl: 350
• Erscheinungstermin: 15. November 2023
• Englisch
• ISBN-13: 9780443136283
• Artikelnr.: 69456742

Autorenporträt

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

Inhaltsangabe

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