Supply Chain Planning for Clinical Trials
A Practical Guide
Ensure your clinical trial supply chain is running smoothly with this practical guide
Clinical trials are a critical part of the pharmaceutical development process. These trials cannot proceed without timely and regular receipt of the drugs being tested, which can prove a challenge for drug manufacturers who have not yet established the structures required to produce quality-controlled specimens of the drug at scale. Managing supply chains of pre-production drugs for clinical trials is therefore an essential component of drug development.
Supply Chain Planning for Clinical Trials offers a practical introduction to this process for researchers and industry professionals. Beginning with the basics of creating a demand plan, it proceeds step by step through the management of supply in a clinical trial, covering all major underlying factors. The result is a thorough overview that addressed every possible challenge in the clinical trial and drug development process.
Supply Chain Planning for Clinical Trials readers will also find:
* Tools for minimizing risk and expense by optimizing the relationship between supply and demand
* Detailed discussion of topics including expiry planning, developing reports and metrics, and many more
* Excel-based models to illustrate key concepts, adaptable to the readers' specific scenarios
Supply Chain Planning for Clinical Trails is ideal for pharmaceutical industry professionals involved in clinical trial supply planning, as well as academics and researchers interested in the pharmaceutical industry and its logistics.
Chapter 2: Introduction to Clinical Trials
Chapter 3: Introduction to the Clinical Trial Supply Chain
Chapter 4: Quality Considerations
Chapter 5: Regulatory Considerations
Chapter 6: RTSM and Its Role in the Clinical Supply Chain
Chapter 7: Supply Chain Planning for Clinical Trials
Chapter 8: Finished Product Demand Planning: Basic Concepts
Chapter 9: Finished Product Supply Planning: The Production Plan
Chapter 10: Finished Product Expiry Planning
Chapter 11: Finished Product Supply Planning: The Distribution Plan
Chapter 12: Upstream Supply Planning: Primary Packaging, Drug Product, and Drug Substance
Chapter 13: Advanced Concepts in Demand and Supply Planning
Chapter 14: Clinical Supply Chain Reports, Budgets, and Metrics
Chapter 15: Clinical Supply Chain Planning Processes
Chapter 16: A Week in the Life of a Clinical Planner
Chapter 17: Comparator and Ancillary Planning
Chapter 18: Make-to-Order and Just-in-Time Supply Chains in Clinical Trials
Chapter 19: Direct-to-Patient Supply Chain Management
Chapter 20: Contract Organization Management and Oversight
Chapter 21: International Logistics for Clinical Biopharmaceutical Products
Chapter 22: Clinical Supply Chain Planning Tools and Technology
Chapter 23: Integrating the Clinical Supply Chain into a Commercial Launch
Appendix: Clinical Supply Chain Planning Data Elements and Formulas
Glossary
Index
