Clinical Trial Supply

Summary

The definitive guide:

• Written by industry experts
• Edited and produced by the leading outsourcing publisher and consultancy

Contents include:

• Development, formulation and manufacture
• Analytical development
• Packaging and labelling
• The regulatory challenge
• Logistics and distribution
• Automation
• CTS in emerging markets
• Market size and trends

Contents

• Chapter 1 Clinical Trial Supplies - The Essential Ingredients
  • 1. Introduction
  • 2. CTS, a Definition
  • 3. Outsourcing
  • 4. Clinical Trials Supplies, Activities
  • 4.1 Manufacturing
  • 4.2 Packing
  • 4.3 Labelling
  • 4.4 Storage, Warehousing and Distribution
  • 4.5 Reconciliation and Destruction of CTS
  • 4.6 Process Improvement
  • 4.7 Quality
  • 5. The Market for CTS
  • 5.1 CTSO, a Definition
  • 5.2 Location
  • 5.3 Classification of CTSOs
  • 5.4 Growing the CTS Business
  • 5.5 Annual Revenue of CTSOs
  • 5.6 Number of Employees of CTSOs
  • 5.7 CTSO Facilities and Global Scope
  • 5.8 Clinical Trial Supply Services
  • 6. Client Survey
  • 6.1 Why Outsource Clinical Trial Supplies
  • 6.2 Criteria for Choosing a CTSO
  • 6.3 CTS Services Availablitity
  • 7. Forecasting CTS Business - the Challenge
• Chapter 2 Development, Formulation and Manufacture of Investigational Medicinal Products
  • 1. Introduction
  • 2. Drug Discovery
    • 2.1 Stages in the Development of New Medicines
    • 2.2 Chemical, Pharmaceutical and Biological Screening
    • 2.3 Pre-clinical Toxicological Testing
  • 3. Formulation of Dose Form
  • 3.1 Pre-formulation
  • 3.2 Modified Release Dosage Forms
  • 3.3 Drug Pharmacokinetics
  • 3.4 Product Specification
  • 3.5 Stability Testing
  • 4. Manufacture of Investigational Medicinal Product
  • 4.1 Regulatory Framework
  • 4.2 Quality Characteristics
  • 4.3 Good Manufacturing Practice
• Chapter 3 The Role of Analytical Development in CTS
  • 1. Introduction
  • 2. Regulatory Considerations
  • 3. Development of Appropriate Analytical Methodologies
  • 3.1 Analytical Methods for Phase I Clinical Trial Materials
  • 3.2 Analytical Methods for Phase II and III Clinical Trial Materials
  • 3.2.1 Excipient Compatibility Studies
  • 3.2.2 High Performance Liquid Chromatography
  • 3.2.3 Pharmaceutical Performance
  • 3.2.4 Feasibility Batches
  • 3.2.5 Verification of Cleaning Methods
  • 4. Validation of Analytical Methodologies
  • 5. Stability Programs
  • 6. Placebo Formulations
  • 7. Blinded Clinical Comparators
• Chapter 4 Packaging Types
  • 1. Introduction
  • 2. Technical
  • 2.1 Primary Packaging
  • 2.1.1 Blistering/Foils
  • 2.1.2 Bottling
  • 2.1.3 Child Resistant Packaging
  • 2.2 Secondary Packaging
  • 2.2.1 Blinding
  • 2.2.2 Assembly
  • 2.3 Labelling
  • 2.3.1 Application
  • 2.3.2 Standard/Booklets/JIT
  • 2.3.3 Labelling at Controlled temperature
  • 3. Summary
• Chapter 5 CTS - The Regulatory Challenge
  • 1. Introduction
  • 2. History
  • 3. The Regulatory Framework in Europe
  • 4. Interpretation of European Requirements
  • 4.1 Clinical Trial Applications/Ethics
  • 4.2 The Role of the Qualified Person
  • 4.3 Manufacturing Authorisation
  • 4.4 Product Specification File
  • 4.5 Label Requirements
  • 4.6 Expiry Dating
  • 4.7 Importation into Europe
  • 4.8 GMP
  • 4.9 Inspections
  • 5. United States
  • 5.1 Regulations and Guidances
  • 5.2 Label Requirements
  • 5.3 Child Resistant Packaging
  • 6. Active Pharmaceutical Ingredient
  • 7. Compassionate Use and Named Patient Supply
  • 8. Drug Device Combinations
  • 9. Conclusions
• Chapter 6 Automated Logistics and Distribution
  • 1. Introduction
  • 2. The Clinical Trials Environment and Implications for Clinical Supplies
  • 2.1 Major Pharmaceutical Companies
  • 2.2 Biotechnology
  • 2.3 Commercialisation of Biopharm Products
  • 2.4 European Union Expansion
  • 2.5 IVR Driven Studies
  • 2.6 Consolidation of Clinical Supplies
  • 2.7 Summary of Implications
  • 3. The Application of Technology and Automation in Clinical Distribution
  • 3.1 Receipt and Processing of Distribution Orders
  • 3.2 Picking and Packing of Orders
  • 3.3 Couriers and Web Technology
  • 4. The Use of Information Technology to Optimise the Supply Plan
  • 5. The Extension of IVR Technology
  • 6. Trial Simulation and Forecasting
• Chapter 7 Supplying the Needs of Emerging Markets
  • 1. Introduction
  • 2. Why Perform Clinical Trials in Emerging Markets
  • 3. Which Regions are Considered Emerging Markets?
  • 3.1 Asia
  • 3.2 India
  • 3.3 Central and Eastern Europe
  • 3.4 Latin America
  • 3.5 Africa
  • 4. Logistical Challenges
  • 5. Selection of Market Partners
  • 6. Obtaining Import Licences
  • 7. Use of Strategic Distribution Depots
  • 7.1 Direct to Site Distribution
  • 7.2 Distribution to Local Depots
  • 7.3 Hybrid Approaches
  • 8. Cold Chain Management
  • 8.1 Packaging for Maintenance of Temperature Control
  • 8.2 Use of Monitoring Devices
  • 8.3 Transit Times
  • 8.4 Planning for Deviations
  • 9. Conclusion
• Chapter 8 A Note on Scheduling, Planning and Project Management
  • 1. Planning for CTS
  • 2. The Phases of a Project
  • 2.1 Initiation
  • 2.2 Specification
  • 2.3 Design
  • 2.4 Implementation/Operations
  • 3. Risk Analysis
  • 3.1 Identify the Risks
  • 4. Milestones
  • 5. Controlling Projects
  • 5.1 Taking action