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Market Research Report

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

Published by GBI Research Product code 249119
Published Content info 56 Pages
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Clinical Supply Chain Management - Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management
Published: August 22, 2012 Content info: 56 Pages


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.


  • 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.

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.

Table of Contents

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Clinical Supply Chain Management - Introduction

3. Clinical Supply Chain Management - Overview

  • 3.1. Overview of Clinical Supply Chains
    • 3.1.1. Evolution of Clinical Supply Chains

4. Clinical Supply Chain Management - Industry Analysis

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

5. Clinical Supply Chain Management - Drivers and Restraints

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

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

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

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

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

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

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

9. Clinical Supply Chain Management - Technological Landscape

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

10. Clinical Supply Chain Management - Regulatory Landscape

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

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

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

12. Clinical Supply Chain Management - Appendix

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

List of Tables

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

List of Figures

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