Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Management

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Time and Cost Reduction in Clinical Trials- Outsourcing and IT to
Optimize Patient Recruitment, Logistics, Data and Site Management
Published on June 2011

Report Summary

Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site
Management

Summary

GBI Research, the leading business intelligence provider, has released its latest research, 'Time and Cost Reduction in Clinical Trials-
Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Management'. The report provides in-depth analysis of
the major factors which lead to time and cost efficient clinical trials. The report analyzes the importance of implementation of IT to get
error-free data related to patient recruitment, patient responses, site management and logistics.

Clinical trials are one of the most important parts of the drug development process. The various aspects involved in clinical trials such
as implementation of technology, efficient supply chain management, proper site selection, patient recruitment, database
management and others are important.

At present the rate of new drug approvals is declining with every passing year. Biopharmaceutical companies are under huge
pressure to reduce the time required for drug development. It is equally important to cut costs of drug development so that adequate
revenue generation can be maintained by pharmaceutical companies. Patent expiration of major drugs is leading to a reduction in the
revenue generated by pharmaceutical companies. Biopharmaceutical companies therefore need to consider new approaches which
will lead to time and cost reduction in clinical trials without affecting the quality of the trials.

GBI Research finds that it is very important for the pharmaceutical industry to launch new drugs in the market in order to maintain
revenue generation. Large sums of money are invested by pharmaceutical companies for the development of drugs. Revenue
generated by pharmaceutical companies is dependent upon the patent period of the drug, and many drugs are facing the challenge of
patent expiry.

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

Scope

The scope of this report includes -
- Description of clinical trial phases.
- Analysis of the leading techniques which will lead to cost efficient conduction of clinical trials.
- Analyzes how the use of surrogate endpoints reduces the duration of clinical trials, leading to reduced study timelines.
- Analysis of the impact of IT solutions to reduce the cost of clinical trials.
- Description of the ways in which outsourcing helps in minimizing time and cost required for clinical trials.
- Analysis of efficient clinical trial site management so that completion of a trial is done on time.
- Detailed case studies to highlight the impact of IT and outsourcing on clinical trial cost reduction.

Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Management (From Slideshare) Page 1/8


Reasons to buy

The report will enhance your decision making capability. It will allow you to -
- Develop strategy to implement IT for time and cost efficient patient recruitment, data and site management.
- Develop market knowledge about key companies to which outsourcing of clinical trials can be done. Key deals of CROs are
discussed in detail.
- Develop strategies by identifying the key components which can lead to reduced study timelines.
- Ensure efficient clinical trial outcome by implementing CDISC standards.
- Develop effective business strategies related to clinical trials through the analytical insight gained from case studies.
- Ensure success of clinical trial management by analysis of adequate techniques.

Table of Content

1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 8
2 Time and Cost Reduction in Clinical Trials- Introduction 9
2.1 GBI Research Report Guidance 9
3 Time and Cost Reduction in Clinical Trials- Clinical Trial Process 10
3.1 Introduction 10
3.1.1 The Clinical Research Process 10
3.1.2 Clinical Trial Process and Types of Clinical Trial Outcomes 13
4 Biomarkers and Surrogate End-points Help in Reducing Time and Cost of Clinical Trials 15
5 Site Selection and Management - Facilitates Cost and Time Efficient Clinical Trial 18
5.1 Timely Site Initiation is Mandatory for Completion of Clinical Trials on time 18
5.1.1 Site Initiation Process 18
5.1.2 Key Factors for Minimizing Site Initiation Delays 19
5.1.3 Site Management Organizations (SMOs) - Reduces Study Timeline 21
6 Effective and Efficient Supply Chain Management Reduces Time Lag 22
6.1 Key Factors for Efficient Supply Chain Management in Clinical Trials 22
6.1.1 Planning Issues 22
6.1.2 Manufacturing Issues 23
6.1.3 Distribution Issues 24
6.1.4 Visibility Issues 24
6.2 e-Clinical Trial Solutions in Operational Planning 24
6.2.1 Clinical Trial Supply Management System (CTSM) 24
6.2.2 Radio Frequency Identification (RFID) Tag Architectures 26
6.2.3 RFID IT Architecture 26
7 Information Technology Helps in Improving Clinical Trial Management 27
7.1 Introduction 27
7.2 Electronic Data Capture (EDC) 28
7.2.1 Cost Saving Scenario in EDC 31
7.2.2 Software as a Service (SaaS) based EDC 33
7.2.3 Case Studies 34
7.3 Interactive Voice Response System (IVRS) 35



7.3.1 The IVRS Provides the Real Time Clinical Trials Data Tracking for The Following 36
7.3.2 Case Study 37
7.4 ePRO (Electronic Patient Reported Outcomes) 39
7.5 EHR (Electronic Health Record) 41
7.6 Clinical Trial Management System (CTMS) 42
7.7 Cost Saving By Predictive Modeling Tool 44
7.7.1 ROI of Predictive Modeling Tools 44
8 Implementation of Clinical Data Interchange Standards Consortium (CDISC) Standards Reduces Cost of Clinical Trials 46
8.1 Various Standards in CDISC 46
8.1.1 Adoption of Various Standards 47
8.1.2 Cost Saving for a Single Study 48
8.1.3 Revenue Gained for a Single Product 49
9 Outsourcing- Contract Research Organizations (CROs) are Re-defining the Conduct of Clinical Trials 50
9.1 Introduction 50
9.2 Contract Research Organizations (CROs) 51
9.2.1 Clinical Research Outsourcing is seen as a Solution to Problems such as Rising Costs or Low Productivity 51
9.2.2 Strategic Outsourcing Delivers Greater Value by Understanding the Core Competencies of the Vendor and Outsourcing
Companies 51
9.3 Key Reasons for Outsourcing to Contract Research Organizations 52
9.3.1 Desire to Reduce Costs is a Prime Reason for Contract Research Outsourcing 53
9.3.2 CROs are Engaged to Reduce Time to Market in order to Achieve Competitive Edge 53
9.3.3 Outsourcing Resource and Time Intensive Functions such as Data Management Allows Biopharmaceutical Companies to Focus
on Core Competencies 54
9.3.4 Evolving Risk Sharing Agreements Attract Biopharmaceutical Companies to Increase Contract Research Outsourcing 54
9.3.5 CROs are Helping to Improve the Clinical Research Quality through Better Regulatory Understanding and Keeping Pace with
Technological Advances 54
9.3.6 Small and Medium Biopharmaceutical Companies can Leverage on the Resources of CROs 55
9.3.7 Biopharmaceutical Companies Benefit from New Technologies that a CRO Has Access to 55
9.4 Cost of Clinical Trial is reduced by Outsourcing by a Significant Amount 56
9.4.1 Cost of Conducting Clinical Trials in India is Approximately 55% of the Cost of Conducting a Clinical Trial in the US 56
9.5 Contract Research Outsourcing ' Service Models 57
9.5.1 Contract Research Outsourcing Service Model 57
9.5.2 Criteria for Selecting a CRO 60
9.5.3 Early Stage Drug Development Outsourcing 61
9.5.4 Clinical Stage Drug Development Outsourcing 63
9.5.5 Late Stage Development Outsourcing 65
10 Profile of Key Companies Dealing in Clinical Trial Processes 67
10.1 Paragon Biomedical 67
10.1.1 Overview 67
10.2 Exodon 67
10.2.1 Overview 67
10.3 D. Anderson & Co. 67
10.3.1 Overview 67
10.4 KIKA Medical 67
10.4.1 Overview 67
10.5 Omnicomm Systems 68
10.5.1 Overview 68
10.6 eResearch Technology 68



10.6.1 Overview 68
10.7 Prelude Dynamics 68
10.7.1 Overview 68
10.8 Clinipace 68
10.8.1 Overview 68
10.9 Phase Forward 69
10.9.1 Overview 69
10.9.2 Key M&A Deals and Alliances 69
10.10 Perceptive Informatics 69
10.10.1 Overview 69
10.11 DZS/ Clinplus 70
10.11.1 Overview 70
10.12 Quintiles 70
10.12.1 Overview 70
10.13 Covance 71
10.13.1 Overview 71
10.14 Pharmaceutical Product Development (PPD) 72
10.14.1 Overview 72
10.15 Charles River Laboratories 73
10.15.1 Overview 73
10.16 PAREXEL International 74
10.16.1 Overview 74
11 Appendix 75
11.1 Market Definitions 75
11.2 Abbreviations 75
11.3 Research Methodology 76
11.3.1 Coverage 76
11.3.2 Secondary Research 76
11.3.3 Primary Research 77
11.3.4 Expert Panel Validation 77
11.4 Contact Us 77
11.5 Disclaimer 77
11.6 Sources 78

1.1 List of Tables

Table 1: Time and Cost Reduction in Clinical Trials, Factors for Minimizing Time Delays in Site Initiation, 2010 19
Table 2: Time and Cost Reduction in Clinical Trials, Cost of Query Resolution- Comparison of Paper based and EDC based Query
Resolution Cost, 2010 34
Table 3: Time and Cost Reduction in Clinical Trials, Cost of Monitoring- Comparison of Paper Based and EDC Based Trial Monitoring,
2010 34
Table 4: Time and Cost Reduction in Clinical Trials, Role of EHR in Clinical Trial Process, 2010 41



Table 5: Time and Cost Reduction in Clinical Trials, Cost Comparison, The US vs. India, ($'000), 2009 56
Table 6: Time and Cost Reduction in Clinical Trials, Outsourcing Models for Drug Development, 2010 57

1.2 List of Figures
Figure 1: Time and Cost Reduction in Clinical Trials, Clinical Research Process, 2010 10
Figure 2: Time and Cost Reduction in Clinical Trials, Clinical Trial Process, 2010 13
Figure 3: Time and Cost Reduction in Clinical Trials, Types of Clinical Trial Outcome, 2010 13
Figure 4: Time and Cost Reduction in Clinical Trials, Surrogate Endpoint ' Not Causal Pathway of Disease Process, 2010 15
Figure 5: Time and Cost Reduction in Clinical Trials, Surrogate-Affected by Intervention, 2010 16
Figure 6: Time and Cost Reduction in Clinical Trials, Surrogate - Not in the Pathway of Intervention, 2010 16
Figure 7: Time and Cost Reduction in Clinical Trials, Mode of Action (MoA) of Intervention is Independent of Disease Process, 2010
17
Figure 8: Time and Cost Reduction in Clinical Trials, Site Initiation Process, 2010 18
Figure 9: Time and Cost Reduction in Clinical Trials, Key Factors Responsible for Study Timeline Reduction by SMOs, 2010 21
Figure 10: Time and Cost Reduction in Clinical Trials, Supply Chain in Clinical Trials, 2010 23
Figure 11: Time and Cost Reduction in Clinical Trials, Clinical Trial Supply Management System, 2010 25
Figure 12: Time and Cost Reduction in Clinical Trials, RFID Technologies in Clinical Trials, 2010 26
Figure 13: Time and Cost Reduction in Clinical Trials, Clinical Trial Data Management by IT, 2010 27
Figure 14: Time and Cost Reduction in Clinical Trials, Paper CRF Method of Data Capturing, 2010 29
Figure 15: Time and Cost Reduction in Clinical Trials, Electronic Data Capture through e-CRF, 2010 30
Figure 16: Time and Cost Reduction in Clinical Trials, EDC System- Cost Saving Scenario, 2010 31
Figure 17: Time and Cost Reduction in Clinical Trials, Data Quality Gap Between Electronic and Paper Based Data Capturing, 2010
32
Figure 18: Time and Cost Reduction in Clinical Trials, SaaS based EDC System, 2010 33
Figure 19: Time and Cost Reduction in Clinical Trials, Use of IVRS in Shipment Request Process for Inventory Management, 2010 35
Figure 20: Time and Cost Reduction in Clinical Trials, Cost Saved by Using IVRS ' Reduction in Overages, 2010 37
Figure 21: Time and Cost Reduction in Clinical Trials, Cost of Over-Recruitment by 10% in Different Study Samples, 2010 38
Figure 22: Time and Cost Reduction in Clinical Trials, Cost Saving Scenario of ePRO Solutions, 2010 39
Figure 23: Time and Cost Reduction in Clinical Trials, Case Study of ePRO Solutions, 2010 40
Figure 24: Time and Cost Reduction in Clinical Trials, Support of EHR in Clinical Trials, 2010 41
Figure 25: Time and Cost Reduction in Clinical Trials, A Typical Clinical Trial Management System, 2010 43
Figure 26: Time and Cost Reduction in Clinical Trials, Cost Saving Scenario of a Predictive Modeling Solution, 2010 45
Figure 27: Time and Cost Reduction in Clinical Trials, Adoption % of CDISC Standards, 2004/2005 and 2007 47
Figure 28: Time and Cost Reduction in Clinical Trials, Cost Saving for a Single Study Using CDISC, 2010 48
Figure 29: Time and Cost Reduction in Clinical Trials, Revenue Gained for a Single Product Using CDISC, 2010 49
Figure 30: Time and Cost Reduction in Clinical Trials, Contract Research Outsourcing ' Reasons for Outsourcing, 2010 52
Figure 31: Time and Cost Reduction in Clinical Trials, Contract Research Outsourcing- Fully Integrated Service Model, 2010 58
Figure 32: Time and Cost Reduction in Clinical Trials, Contract Research Outsourcing- Functional Service Model, 2010 59
Figure 33: Time and Cost Reduction in Clinical Trials, Strategic or Tactical Advantages in Early Stage Drug Development
Outsourcing, 2010 61
Figure 34: Time and Cost Reduction in Clinical Trials, Strategic or Tactical Advantages of Outsourcing in Clinical Stage of the Drug
Development Process, 2010 63
Figure 35: Time and Cost Reduction in Clinical Trials, Strategic or Tactical Advantages of Outsourcing in Late Stage of the Drug
Development Process, 2010 65

Companies Mentioned
Paragon Biomedical
Exodon



D. Anderson & Co
KIKA Medical
Omnicomm Systems
eResearch Technology
Prelude Dynamics
Clinipace
Phase Forward
Perceptive Informatics
DZS/ Clinplus
Quintiles
Covance
Pharmaceutical Product Development (PPD)
Charles River Laboratories
PAREXEL International


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