Clinical Research: Logistics, Management and Practical Aspects - Clinical Operations Treatise

Research Methodology · Clinical Bases

How it begins

A comprehensive and systematic treatise on methodological design, global bioethics regulatory frameworks, advanced pharmaceutical logistics of investigational products, clinical site operations under data integrity standards, and complex state-of-the-art clinical monitoring strategies.

What it covers

1. · The Progression of the Clinical Phases
2. · Evolution of Bioethical Codes
3. · The Investigational Drug (IP) and its Packaging
4. · Feasibility Evaluation (Site Feasibility)
5. · Source Data Verification (SDV) vs. Source Data Review (SDR)
6. · The Clinical Trial Contract (CTA)
7. · Classification of Adverse Events
8. · The Life Cycle of Clinical Data
9. · Decentralized Clinical Trials (DCTs)
10. · The Clinical Site Closure Process (Close-Out)