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Clinical Supply Chain Management - Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management

Executive Summary

Testing, Testing: Clinical Trials Making the Move to Emerging Countries

In an attempt to save time, money and resources, international pharmaceutical companies are increasingly out-sourcing clinical trials to countries in Asia, Latin America and Eastern Europe, according to a new report by industry experts GBI Research.

The business intelligence outfit's latest study*states that with squeezed Research and Development (R&D) budgets, Big Pharma is finding greater value in employing Contract Research Organizations (CROs) in emerging nations for the management of clinical trials.

CROs and discovery research outsourcing companies specialize in conducting preclinical and clinical research and provide a faster service with the benefit of economies of scale which enable companies to cover a large number of molecules and identify unsuccessful compounds more quickly.

Drug discovery companies such as Advinus, WuXi AppTec and Aurigene have all delivered their targets ahead of schedule and helped the big pharmaceutical companies to accelerate their drug research at considerably lower costs.

Every drug that fails to make it through clinical testing represents a financial loss, and therefore smart pharmaceutical companies have been entering into risk-sharing agreements with CROs that profit both sides should a drug become marketable, while also distributing the monetary burden of failed medications.

With the benefits of employing CROs based in developing countries proving to be a major point of consideration for Big Pharma, the total number of clinical trials conducted in the US has fallen from 60% of the global sum in 2002 to 40% in 2010.

In 2010, Europe carried out 25% of all clinical trials, while East Asia accounted for 10%. Canada, the Middle East, South America and India followed with 6.1%, 4.0%, 3.0% and 2.5%, respectively.

Clinical Supply Chain Management - Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management

This report focuses on the current scenario of clinical supply chain management. Key segments of the clinical supply chain which are covered in the report include labelling, packaging, warehousing, logistics, distribution and destruction of investigational products.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

Abstract

Clinical Supply Chain Management - Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management

Summary

GBI Research, leading business intelligence provider has released its latest research report, entitled "Clinical Supply Chain Management - Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management". The report focuses on the current scenario of clinical supply chain management. Key segments of the clinical supply chain which are covered in the report include labeling, packaging, warehousing, logistics, distribution and destruction of investigational products.

There has been an increase in the number of developmental drugs, and an expansion in clinical trial sites and the complexity of clinical trials. There has also been an increase in the total number of procedures undertaken per clinical trial.

Clinical Supply Chain Management (CSCM) is vital in conducting clinical trials. Geographic expansion, the complexity of drugs used in clinical trials and the increased attention of pharmaceutical companies on efficient R&D are the three main reasons for having proper CSCM in place. Accurate and timely delivery of clinical trial material to the clinical trial site is critical for the success of a clinical trial. The chance of meeting the research milestones increases by considering clinical supply processes from the planning stage of the clinical trials.

Although there are many advantages of tracking clinical trial products, it is very difficult to have an efficient process in place to track inventory. Use of new technologies is done to make tracking more efficient and effective. Pharmaceutical companies are looking for better avenues, such as Contract Research Organizations (CROs) who have dedicated departments that leverage information technology to rejuvenate their business model, particularly R&D, and make it more agile, lean and global. Information technology provides significant potential to make this happen through various services, which include globally integrated data management, paperless clinical trials and many others.

Scope

  • Segmentation of the clinical supply industry by its major components such as logistics and inventory management.
  • Key challenges and unmet needs of the clinical supply chain management industry.
  • Analysis of technologies such as IVRS/IWRS, RFID and others which are used for efficient clinical supply chain operations.
  • Regulatory landscape of countries such as China, India, Russia and South Africa.
  • Key parameters which are considered for choosing the clinical supply vendor.
  • Profiles of key companies which deal in clinical supply chain management.
  • Analysis of factors which are considered for outsourcing the clinical supply chain to other companies.

Reasons to buy

  • Decide on the existing market scenario in clinical supply chain management.
  • Analyze the requirements for regulatory compliance for clinical supply chain management.
  • Gain knowledge of key challenges and unmet needs for the clinical supply chain management industry.
  • Develop strategies for quality control of clinical supply materials.
  • Develop risk mitigation strategies to enhance risk management.

TOC

1 Table of Contents

1 Table of Contents 5

  • 1.1 List of Tables 7
  • 1.2 List of Figures 7

2 Clinical Supply Chain Management - Introduction 8

3 Clinical Supply Chain Management - Overview 9

  • 3.1 Overview of Clinical Supply Chains 9
    • 3.1.1 Evolution of Clinical Supply Chains 11

4 Clinical Supply Chain Management - Industry Analysis 12

  • 4.1 Capital Requirement 12
  • 4.2 Skilled Workforce 13
  • 4.3 Competition Among Existing Players 13

5 Clinical Supply Chain Management - Drivers and Restraints 14

  • 5.1 Drivers 14
    • 5.1.1 Increasing Concern for Pharmaceutical Companies to Improve R&D Outcomes 14
    • 5.1.2 Geographic Expansion for Conducting Clinical Trials 14
  • 5.2 Restraints 15
    • 5.2.1 Complex Regulatory System 15
    • 5.2.2 High Cost Involved for Entering the Market and Maintaining Processes 15
    • 5.2.3 Proper Visibility of Products in the Supply Chain (Inventory Visibility and Traceability) 15

6 Clinical Supply Chain Management - Components of the Clinical Supply Chain 16

  • 6.1 Labeling 16
  • 6.2 Packaging 17
    • 6.2.1 Blister Packaging 17
    • 6.2.2 Plastic Bottles 18
    • 6.2.3 Labels and Accessories 18
    • 6.2.4 Pouches and Strip Packs 18
    • 6.2.5 Caps and Closures 18
    • 6.2.6 Secondary Containers 18
    • 6.2.7 Others 18
  • 6.3 Logistics 19
    • 6.3.1 Focus Areas for Logistics 20
  • 6.4 Distribution Models 21
    • 6.4.1 Outsource 22
    • 6.4.2 Build 22
    • 6.4.3 Acquisition 22
    • 6.4.4 Direct Shipping 23
    • 6.4.5 Co-Development 23
  • 6.5 Inventory Management 23
  • 6.6 Destruction and Disposal of Waste 24
    • 6.6.1 Recording of Destruction 24
    • 6.6.2 Methods of Destruction 24

7 Clinical Supply Chain Management - CROs Operate in Clinical Trial Supplies 25

  • 7.1 Key Reasons for Outsourcing of Clinical Trials and Research Processes 25
    • 7.1.1 Different Strategies Adopted by Pharmaceutical Companies to Increase Efficiency 26
    • 7.1.2 Increase in the R&D Costs Against Revenue Growth is a Reason for Outsourcing Clinical Trials to CROs 26
    • 7.1.3 Increasing Drug Failure Rates a Concern for Pharmaceutical Companies 27
    • 7.1.4 Outsourcing Clinical Trials to CROs in Order to Decrease the Time Required for Launching the Product in the Market 27
    • 7.1.5 Outsourcing to Site Management Organizations (SMO) 28
    • 7.1.6 Minimization of Development Risks Through Risk Sharing with CROs is One of the Key Reasons for Outsourcing 29
    • 7.1.7 CROs Can Effectively Manage the Trends in Regulations Governing Clinical Trials 30
  • 7.2 Factors Leading to CSMO Growth 30

8 Clinical Supply Chain Management - Key Challenges for Effective and Efficient Supply Chain Management 31

  • 8.1 Key Factors for Efficient Supply Chain Management in Clinical Trials 31
    • 8.1.1 Planning Issues 31
    • 8.1.2 Manufacturing Issues 31
    • 8.1.3 Distribution Issues 32
    • 8.1.4 Visibility Issues 32
    • 8.1.5 Technical Integration with the Vendors 32

9 Clinical Supply Chain Management - Technological Landscape 33

  • 9.1 Information Technology in R&D 33
    • 9.1.1 Data Management 34
    • 9.1.2 Clinical Data Management System 34
    • 9.1.3 Clinical Data Management Outsourcing 35
    • 9.1.4 Deals in Clinical Trial Data Management Outsourcing 35
  • 9.2 IVRS/IWRS 36
    • 9.2.1 IVRS Provides Real-Time Clinical Trials Data Tracking for the Following 37
    • 9.2.2 Case Study 39
  • 9.3 Clinical Data Management Systems (CDMS)/Clinical Trial Management Systems (CTMS) 40
  • 9.4 Electronic Data Capture (EDC) 41
  • 9.5 Clinical Trial Management System (CTMS) 41
  • 9.6 Radio Frequency Identification (RFID) 42

10 Clinical Supply Chain Management - Regulatory Landscape 43

  • 10.1 The US 43
    • 10.1.1 Important Regulations by the FDA in Proposal 43
    • 10.1.2 FDA Motivating CROs to Use Adaptive Design in Drug Development 43
  • 10.2 Europe 44
    • 10.2.1 The New Pharmacovigilance Legislation 45
    • 10.2.2 Reasons for Passing the New Legislation 45
  • 10.3 Emerging Markets 45
  • 10.4 India 46
    • 10.4.1 Potential Advantages of the Indian CRO Market 46
  • 10.5 China 47
    • 10.5.1 Potential Advantages of the Chinese CRO Market 47

11 Clinical Supply Chain Management - Profiles of Key Players and Key Deals 49

  • 11.1 Profiles of Key Companies in Clinical Supply Chain Management 49
    • 11.1.1 Medidata 49
    • 11.1.2 Catalent 49
    • 11.1.3 Myoderm 49
    • 11.1.4 Cold Chain Technologies 49
    • 11.1.5 Numoda Corporation 49
    • 11.1.6 Fisher Clinical Services 50
    • 11.1.7 Marken 50
    • 11.1.8 Phase Forward 50
    • 11.1.9 Bilcare Global Clinical Supplies 50
    • 11.1.10 Almac Clinical Services 50
    • 11.1.11 BioClinica 51
    • 11.1.12 Aptuit 51
    • 11.1.13 Chiltern 51
  • 11.2 Key Deals among Clinical Supply Management Companies 52
    • 11.2.1 Medidata Solutions Acquired Clinical Force in July 2011 52
    • 11.2.2 Catalent Acquires Clinical Trial Supplies Division of Aptuit LLC in February 2012 52
    • 11.2.3 Ion Beam Applications (IBA) and Bayer Schering Pharma Sign a Deal in 2010 52

12 Clinical Supply Chain Management - Appendix 53

  • 12.1 Market Definitions 53
  • 12.2 Abbreviations 53
  • 12.3 Bibliography 54
  • 12.4 Research Methodology 55
    • 12.4.1 Coverage 55
    • 12.4.2 Secondary Research 55
    • 12.4.3 Primary Research 56
    • 12.4.4 Expert Panel Validation 56
  • 12.5 Contact Us 56
  • 12.6 Disclaimer 56

List of Tables

1.1 List of Tables

  • Table 1: Clinical Supply Chain Management, Clinical Trials in Different Geographies, %, 2012 10
  • Table 2: Clinical Supply Chain Management, R&D Expenditure Versus Turnover for the Top Ten Pharmaceutical Companies, 2011 27

List of Figures

1.2 List of Figures

  • Figure 1: Clinical Supply Chain Management, Investigational Medicinal Products (IMP) Path, 2012 9
  • Figure 2: Clinical Supply Chain Management, Clinical Trials in Different Geographies, %, 2012 10
  • Figure 3: Clinical Supply Chain Management, Illustrative Supply Chain for Clinical Trial Materials, 2012 11
  • Figure 4: Clinical Supply Chain Management, Capital Requirement, Stages, 2012 12
  • Figure 5: Clinical Supply Chain Management, Advantages of Geographic Expansion of Clinical Trials, 2012 14
  • Figure 6: Clinical Supply Chain Management, Types of Clinical Trial Material Packaging, 2012 17
  • Figure 7: Clinical Supply Chain Management, Key Stages in Distribution of Clinical Trial Material, 2012 19
  • Figure 8: Clinical Supply Chain Management, Key Focus Areas for Logistics, 2012 20
  • Figure 9: Clinical Supply Chain Management, Distribution Models, 2012 21
  • Figure 10: Clinical Supply Chain Management, Segments of Distribution Model, 2012 22
  • Figure 11: Clinical Supply Chain Management, Inventory Management Stages, 2012 23
  • Figure 12: Clinical Supply Chain Management, Factors Resulting in Efficient Supply Chain, 2012 25
  • Figure 13: Clinical Supply Chain Management, R&D Expenditure Versus Turnover for the Top Ten Pharmaceutical Companies, 2011 26
  • Figure 14: Clinical Supply Chain Management, Key Factors Responsible for Study Timeline Reduction by SMOs, 2011 28
  • Figure 15: Clinical Supply Chain Management, Site Initiation Process, 2011 29
  • Figure 16: Clinical Supply Chain Management, Technologies Used for Forecasting, 2012 33
  • Figure 17: Clinical Supply Chain Management, Clinical Data Management System Flow, Global, 2012 34
  • Figure 18: Clinical Supply Chain Management, Use of IVRS in the Shipment Request Process for Inventory Management, 2011 37
  • Figure 19: Clinical Supply Chain Management, Cost Saved by Using IVRS - Reduction in Averages, 2011 39
  • Figure 20: Clinical Supply Chain Management, Cost of Over-Recruitment by 10% in Different Study Samples, 2011 40
  • Figure 21: Clinical Supply Chain Management, A Typical Clinical Trial Management System, 2011 42
  • Figure 22: Clinical Supply Chain Management, EU Legislations, 2011 44
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