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Outsourcing

Clinical Trial Supply


Publication Date   January 2007
Publisher   Biopharm Knowledge Publishing
Product Type  
Pages   131
ISBN Number   not applicable
Product Code   BKP003
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Price £595.00

approximately: $1,112 | €755

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

Content


  • 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