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

GBI Research
Published Date » 2012-08-22
No. Of Pages » 56

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.
Table of Contents

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


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


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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