Sections
| Title | Starting Page | Number of Pages |
|---|
| Table of Contents | 5 | 3 |
| List of Tables | 7 | 1 |
| List of Figures | 7 | 1 |
| Clinical Supply Chain Management - Introduction | 8 | 1 |
| Clinical Supply Chain Management - Overview | 9 | 3 |
| Overview of Clinical Supply Chains | 9 | 2 |
| Evolution of Clinical Supply Chains | 11 | 1 |
| Increasing Importance of Forecasting for Clinical Supplies | 11 | 1 |
| Clinical Supply Chain Management - Industry Analysis | 12 | 2 |
| Capital Requirement | 12 | 1 |
| Skilled Workforce | 13 | 1 |
| Competition Among Existing Players | 13 | 1 |
| Clinical Supply Chain Management - Drivers and Restraints | 14 | 2 |
| Drivers | 14 | 1 |
| Increasing Concern for Pharmaceutical Companies to Improve R&D Outcomes | 14 | 1 |
| Geographic Expansion for Conducting Clinical Trials | 14 | 1 |
| Restraints | 15 | 1 |
| Complex Regulatory System | 15 | 1 |
| High Cost Involved for Entering the Market and Maintaining Processes | 15 | 1 |
| Proper Visibility of Products in the Supply Chain (Inventory Visibility and Traceability) | 15 | 1 |
| Clinical Supply Chain Management - Components of the Clinical Supply Chain | 16 | 9 |
| Labeling | 16 | 1 |
| Packaging | 17 | 1 |
| Blister Packaging | 17 | 1 |
| Plastic Bottles | 18 | 1 |
| Labels and Accessories | 18 | 1 |
| Pouches and Strip Packs | 18 | 1 |
| Caps and Closures | 18 | 1 |
| Secondary Containers | 18 | 1 |
| Others | 18 | 1 |
| Logistics | 19 | 1 |
| Focus Areas for Logistics | 20 | 1 |
| Availability of IMP | 20 | 1 |
| Proactive Planning | 20 | 1 |
| Contingency Planning | 20 | 1 |
| Inventory Visibility | 20 | 1 |
| Regulatory and Customs Expertise | 20 | 1 |
| Cost Effectiveness | 20 | 1 |
| Distribution Models | 21 | 1 |
| Outsource | 22 | 1 |
| Build | 22 | 1 |
| Acquisition | 22 | 1 |
| Direct Shipping | 23 | 1 |
| Co-Development | 23 | 1 |
| Inventory Management | 23 | 1 |
| Destruction and Disposal of Waste | 24 | 1 |
| Recording of Destruction | 24 | 1 |
| Methods of Destruction | 24 | 1 |
| Return to the Trial Sponsor | 24 | 1 |
| On- Site Destruction | 24 | 1 |
| Clinical Supply Chain Management - CROs Operate in Clinical Trial Supplies | 25 | 6 |
| Key Reasons for Outsourcing of Clinical Trials and Research Processes | 25 | 1 |
| Different Strategies Adopted by Pharmaceutical Companies to Increase Efficiency | 26 | 1 |
| Increase in the R&D Costs Against Revenue Growth is a Reason for Outsourcing Clinical Trials to CROs | 26 | 1 |
| Increasing Drug Failure Rates a Concern for Pharmaceutical Companies | 27 | 1 |
| Outsourcing Clinical Trials to CROs in Order to Decrease the Time Required for Launching the Product in the Market | 27 | 1 |
| Outsourcing to Site Management Organizations (SMO) | 28 | 1 |
| Minimization of Development Risks Through Risk Sharing with CROs is One of the Key Reasons for Outsourcing | 29 | 1 |
| CROs Can Effectively Manage the Trends in Regulations Governing Clinical Trials | 30 | 1 |
| Factors Leading to CSMO Growth | 30 | 1 |
| Clinical Supply Chain Management - Key Challenges for Effective and Efficient Supply Chain Management | 31 | 2 |
| Key Factors for Efficient Supply Chain Management in Clinical Trials | 31 | 1 |
| Planning Issues | 31 | 1 |
| Manufacturing Issues | 31 | 1 |
| Distribution Issues | 32 | 1 |
| Visibility Issues | 32 | 1 |
| Technical Integration with the Vendors | 32 | 1 |
| Clinical Supply Chain Management - Technological Landscape | 33 | 10 |
| Information Technology in R&D | 33 | 1 |
| Data Management | 34 | 1 |
| Clinical Data Management System | 34 | 1 |
| Clinical Data Management Outsourcing | 35 | 1 |
| Individual Project Outsourcing Model | 35 | 1 |
| Full Time Equivalent Model | 35 | 1 |
| Functional Service Provider Model | 35 | 1 |
| Deals in Clinical Trial Data Management Outsourcing | 35 | 1 |
| Tata Consultancy Services - Eli Lilly | 35 | 1 |
| Cognizant - AstraZeneca | 35 | 1 |
| IVRS/IWRS | 36 | 1 |
| IVRS Provides Real-Time Clinical Trials Data Tracking for the Following | 37 | 1 |
| Patient Randomization | 37 | 1 |
| Drug Information | 37 | 1 |
| Clinical Trial Material (CTM) Tracking | 38 | 1 |
| Patient Status | 38 | 1 |
| Case Study | 39 | 1 |
| Use of IVRS Leads to Reduction in Average Medication Cost | 39 | 1 |
| Use of IVRS Leads to Cost Savings by Preventing Over-Recruitment | 40 | 1 |
| Clinical Data Management Systems (CDMS)/Clinical Trial Management Systems (CTMS) | 40 | 1 |
| Electronic Data Capture (EDC) | 41 | 1 |
| Clinical Trial Management System (CTMS) | 41 | 1 |
| Radio Frequency Identification (RFID) | 42 | 1 |
| Clinical Supply Chain Management - Regulatory Landscape | 43 | 6 |
| The US | 43 | 1 |
| Important Regulations by the FDA in Proposal | 43 | 1 |
| Exculpatory Language to Be Used in Informed Consent Form | 43 | 1 |
| Risk Based Approach to Monitoring Strategies | 43 | 1 |
| FDA Motivating CROs to Use Adaptive Design in Drug Development | 43 | 1 |
| Europe | 44 | 1 |
| The New Pharmacovigilance Legislation | 45 | 1 |
| Reasons for Passing the New Legislation | 45 | 1 |
| Emerging Markets | 45 | 1 |
| India | 46 | 1 |
| Potential Advantages of the Indian CRO Market | 46 | 1 |
| China | 47 | 1 |
| Potential Advantages of the Chinese CRO Market | 47 | 2 |
| Clinical Supply Chain Management - Profiles of Key Players and Key Deals | 49 | 4 |
| Profiles of Key Companies in Clinical Supply Chain Management | 49 | 1 |
| Medidata | 49 | 1 |
| Catalent | 49 | 1 |
| Myoderm | 49 | 1 |
| Cold Chain Technologies | 49 | 1 |
| Numoda Corporation | 49 | 1 |
| Fisher Clinical Services | 50 | 1 |
| Marken | 50 | 1 |
| Phase Forward | 50 | 1 |
| Bilcare Global Clinical Supplies | 50 | 1 |
| Almac Clinical Services | 50 | 1 |
| BioClinica | 51 | 1 |
| Aptuit | 51 | 1 |
| Chiltern | 51 | 1 |
| Key Deals among Clinical Supply Management Companies | 52 | 1 |
| Medidata Solutions Acquired Clinical Force in July 2011 | 52 | 1 |
| Catalent Acquires Clinical Trial Supplies Division of Aptuit LLC in February 2012 | 52 | 1 |
| Ion Beam Applications (IBA) and Bayer Schering Pharma Sign a Deal in 2010 | 52 | 1 |
| Clinical Supply Chain Management - Appendix | 53 | 4 |
| Market Definitions | 53 | 1 |
| Abbreviations | 53 | 1 |
| Bibliography | 54 | 1 |
| Research Methodology | 55 | 2 |
| Coverage | 55 | 1 |
| Secondary Research | 55 | 1 |
| Primary Research | 56 | 1 |
| Expert Panel Validation | 56 | 1 |
| Contact Us | 56 | 1 |
| Disclaimer | 56 | 1 |
