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電子臨床試験ソリューション市場:ますます複雑化する臨床試験および正確性・効率性への注目の高まりが試験スポンサーによる新技術の導入を促進

e-Clinical Trial Solutions Market to 2018 - Growing Complexity of Clinical Trials and Increased Focus on Accuracy and Efficiency Drive Trial Sponsors to Adopt Novel Technologies

発行 GBI Research 商品コード 248226
出版日 ページ情報 英文 70 Pages
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電子臨床試験ソリューション市場:ますます複雑化する臨床試験および正確性・効率性への注目の高まりが試験スポンサーによる新技術の導入を促進 e-Clinical Trial Solutions Market to 2018 - Growing Complexity of Clinical Trials and Increased Focus on Accuracy and Efficiency Drive Trial Sponsors to Adopt Novel Technologies
出版日: 2012年07月31日 ページ情報: 英文 70 Pages
概要

当レポートは、世界の医薬品企業およびCRO(開発業務受託機関)に幅広く導入されている電子臨床試験(eクリニカルトライアル)ソリューションについて調査し、電子臨床試験ソリューションの市場規模、導入技術、将来予測、主要地域におけるデータ分析、および将来の市場に影響を及ぼしうる主要イベントの分析とレビューなどを提供しており、産業の主な促進因子・阻害因子・課題、各システムのケーススタディ、主要企業のプロファイルおよび競合情勢などをまとめ、概略下記の構成でお届けいたします。

第1章 目次

第2章 イントロダクション

第3章 概要

  • 臨床試験の計画
  • 臨床データの取得
  • 臨床データの管理
  • 臨床データの分析・報告
  • 電子臨床試験ソリューションの概要

第4章 市場特徴

  • 電子臨床試験ソリューションの市場規模・予測
  • 市場促進因子
  • 市場課題
  • 市場動向
  • 導入動向

第5章 技術動向

  • ビジネスモデル
  • CDISC標準における近年の発展

第6章 競合情勢

  • 競合ベンチマーキング:提供ソリューション別

第7章 付録

図表

目次

Summary

GBI Research, the leading business intelligence provider, has released its latest research, "e-Clinical Trial Solutions Market to 2018 - Growing Complexity of Clinical Trials and Increased Focus on Accuracy and Efficiency Drive Trial Sponsors to Adopt Novel Technologies", which provides key data and analysis of the major factors affecting the market for eClinical trial solutions in the pharmaceuticals industry. The report also analyzes the opportunities and threats in the eClinical trial solutions market, and the key market drivers and barriers to the adoption of eClinical trial solutions in the industry.

The report is based on proprietary databases, primary and secondary research, and in-house analysis by GBI Research's team of industry experts.

Scope

  • Detailed market characterization, including market size and technology adoption, and forecasts until 2018.
  • Data and analysis on the eClinical trial solutions market in the leading geographies of the world - the US, Europe and Asia-Pacific.
  • Analysis and review of the key events and milestones that will impact the future of the global eclinical trial solutions market. Each trend is independently researched to provide qualitative analysis of its implications.
  • Insightful review of key industry drivers, restraints and challenges which are likely to impact the global eclinical trial solutions market in the long run.
  • Case studies on cost cutting in clinical trials for clinical trial management systems, clinical supply chain management systems, clinical data management systems, intellectual voice response systems, e-diaries and standardization.
  • The report also covers information on the leading market players and the competitive landscape.

Reasons to buy

  • Develop business strategies by understanding the trends shaping and driving the eClinical trial solutions market.
  • Drive revenues by understanding key trends, innovative products and technologies, market segments and companies likely to impact the eClinical trial solutions market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with a potentially strong product portfolio, and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
  • What's the next big thing in the eClinical trial solutions market landscape? - Identify, understand and capitalize.

Executive Summary

Pharma Research Companies Dragged into the The Technological Age, as eClinical Trial Solutions Dominate.

The global economic recession has led to many pharma companies cutting their spending, but investments in technology could help to improve the efficiency of clinical trials, states a new report by healthcare experts GBI Research.

The new report shows that eClinicaltrial solutions can increase the annual savings made by a medical research facility, as automated data processing improves functionality, security, compliance and costs within clinical trials.

Pharmaceutical companies are continually looking for better ways to reduce the time from the end-of-study to FDA submission. Delays in collecting, verifying and auditing the accuracy of data, and converting that data into the right format for statistical analysis, must therefore be addressed. As pharmaceutical companies and Clinical Research Organizations (CROs)manage increasing amounts of clinical information, ensuring data integrity and complying with industry standards becomes more important than ever, and minimizing the time between conducting a trial and producing finalized data set is crucial in speeding up the process of getting drugs to the FDA and the market.

GBI Research finds that eClinical trial solutions are widely adopted by pharmaceutical companies and CROs around the world due to the many advantages offered by the technology. Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Electronic Patient Reported Outcomes (ePROs), Radio Frequency Identification Tags (RFIDs) and eDiaries all embody eClinical trial solutions, and the market is witnessing increasing innovation.

The growing complexity of clinical trials and an increased focus on accuracy and costs have brought several eClinical technologies into the market, as companies allocate special budgets to increase their annual savings.

EDC is the most commonly used method for capturing data electronically in clinical trials, replacing paper-based methods. EDC is set to witness huge growth in the next five years, and vendors are ready to take on complex issues in order to meet industry expectations.

However, a high dependence on traditional methods of capturing clinical trial data still holds some pharma companies from investing in eClinical trial solutions. Even with the phenomenal rise in demand, many companies are reluctant to embrace the technological age, for fear of problems caused by initial models. However, currently marketed products are less complex and more user friendly. In the long term future companies must adapt to eClinical technologies, else the overwhelming data volumes that clinical trials provide will cause various issues like loss of data, delays in approval processes and decline in overall Return on Investment (ROI).

e-Clinical Trial Solutions Market to 2018 - Growing Complexity of Clinical Trials and Increased Focus on Accuracy and Efficiency Drive Trial Sponsors to Adopt Novel Technologies

This report provides data and analysis of the major factors affecting the market for eClinical trial solutions in the pharmaceuticals industry. The report also analyzes the opportunities and threats in the eClinical trial solutions market, and the key market drivers and barriers to the adoption of eClinical trial solutions in the industry.

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

1. Table of Contents

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

2. eClinical Trial Solutions Market - Introduction

  • 2.1. Introduction to eClinical Trial Solutions
    • 2.1.1. Need for eClinical Trial Solutions
  • 2.2. Technological Overview

3. eClinical Trial Solutions Market - Overview of eClinical Trials

  • 3.1. Clinical Trial Planning
    • 3.1.1. Clinical Trial Project Planning
    • 3.1.2. Pain Points in Clinical Trial Project Planning
    • 3.1.3. Clinical Trial Supply Chain Planning
    • 3.1.4. Pain Points in Clinical Trial Supply Chain Management
    • 3.1.5. Planning Issues
    • 3.1.6. Manufacturing Issues
    • 3.1.7. Distribution Issues
    • 3.1.8. Visibility Issues
  • 3.2. Clinical Data Capture
    • 3.2.1. Pain Points in Data Capturing
    • 3.2.2. Issues with Paper-Based Data Collection
    • 3.2.3. Issues with Paper-Based Diaries
    • 3.2.4. Issues with Paper-Based Data Management
  • 3.3. Clinical Data Management
    • 3.3.1. Pain Points in Clinical Data Management
  • 3.4. Clinical Data Analysis and Reporting
    • 3.4.1. Pain Points in Clinical Data Analysis and Reporting
  • 3.5. Overview of eClinical Trial Solutions
    • 3.5.1. Clinical Trial Management Systems (CTMS)
    • 3.5.2. Benefits of Clinical Trial Management Systems
    • 3.5.3. Electronic Data Capture (EDC)
    • 3.5.4. Cost Saving Scenario in EDC
    • 3.5.5. Cost Saving Scenario for Phase I and Phase II Trials
    • 3.5.6. SaaS-based EDC
    • 3.5.7. Electronic Patient Report Outcome System (ePRO)
    • 3.5.8. Cost Saving Scenario with eDiaries
    • 3.5.9. ePRO Adoption Rates
    • 3.5.10. Interactive Voice Response Systems (IVRS)
    • 3.5.11. Clinical Data Management Systems (CDMS)
    • 3.5.12. Clinical Trial Supply Chain Management System

4. eClinical Trial Solutions Market - Market Characterization

  • 4.1. Market Size and Forecasts for eClinical Trial Solutions
    • 4.1.1. Clinical Trial Management System Market
    • 4.1.2. Key Players in the CTMS Market
    • 4.1.3. Electronic Data Capture Market
    • 4.1.4. Key Players in the EDC Market
    • 4.1.5. ePRO Market
    • 4.1.6. Key Players in the ePRO Market
    • 4.1.7. IVRS Market
    • 4.1.8. Key Players in the IVRS Market
    • 4.1.9. Emerging Trend of Virtual Clinical Trials
  • 4.2. Market Drivers
    • 4.2.1. Cutting Down Clinical Trial Costs is the Driving Motivation for the Adoption of eClinical Trial Solutions
    • 4.2.2. Improved Data Standardization Increases Adoption of IT Solutions
    • 4.2.3. Adaptive Clinical Trials are Preferred by Large Biopharmaceutical Companies
    • 4.2.4. Increasing Phase III and Phase II Trials Escalates eClinical Solution Adoption
    • 4.2.5. "Expansion of Indication" for the Existing Drugs is a New Market Opportunity
  • 4.3. Market Challenges
    • 4.3.1. The Traditional Approaching Activities of Pharmaceutical Companies Towards eClinical Trial Solutions
    • 4.3.2. Lack of Standardization of Data Collection Methods Might Limit the Value of eClinical Trial Technologies
    • 4.3.3. The Need for Improvisation of Solutions
  • 4.4. Market Trends
    • 4.4.1. Clinical Trial Spending is Increasing at a Faster Rate
    • 4.4.2. R&D Spending is High in the US
    • 4.4.3. Phase II Spending is Highest in the US and Europe
    • 4.4.4. Market Potential for eClinical Solutions by Phases (US and Europe) is Largely from Phase III
    • 4.4.5. Electronic Data Capture will Witness the Highest Investment for the Next Five Years
  • 4.5. Adoption Trends

5. eClinical Trial Solutions Market - Technology Trends

  • 5.1. Business Models
    • 5.1.1. Outsourcing of Clinical Data Management
    • 5.1.2. Individual Project Outsourcing Model
    • 5.1.3. Full Time Equivalent Model
    • 5.1.4. Functional Service Provider Model
    • 5.1.5. The Need for Outsourcing
  • 5.2. Recent Developments in CDISC Standards
    • 5.2.1. SDTM
    • 5.2.2. ADaM
    • 5.2.3. ODM
    • 5.2.4. LAB
    • 5.2.5. CRT-DDS
    • 5.2.6. Protocol standard
    • 5.2.7. CDISC Sponsored Studies Save Time and Costs

6. eClinical Trial Solutions Market: Competetive Landscape

  • 6.1. Competitive Benchmarking by Solution Offerings

7. eClinical Trial Solutions Market - Appendix

  • 7.1. Market Definitions
  • 7.2. Abbreviations
  • 7.3. Bibliography
  • 7.4. Research Methodology
    • 7.4.1. Coverage
    • 7.4.2. Secondary Research
    • 7.4.3. Primary Research
    • 7.4.4. Expert Panel Validation
  • 7.5. Contact Us
  • 7.6. Disclaimer

List of Tables

  • Table 1: eClinical Trial Solutions Market, Global, Phase I: II Cost Saving Scenario by Adopting EDC, 2012
  • Table 2: eClinical Trial Solutions Market, Global, Data Management Set Up Cost in India, 2010
  • Table 3: eClinical Trial Solutions Market, Global, CDISC Sponsored Studies, 2010
  • Table 4: eClinical Trial Solutions Market, Global, Competitive Benchmarking by Solutions Offering, 2012

List of Figures

  • Figure 1: eClinical Trial Solutions Market, Global, Segmentation by Activities, 2012
  • Figure 2: eClinical Trial Solutions Market, Global, Supply Chain in Clinical Trials, 2012
  • Figure 3: eClinical Trial Solutions Market, Global, Paper CRF Method of Data Capturing, 2012
  • Figure 4: eClinical Trial Solutions Market, Global, Typical Clinical Trial Management System, 2012
  • Figure 5: eClinical Trial Solutions Market, Global, Electronic Data Capture Through e-CRF, 2012
  • Figure 6: eClinical Trial Solutions Market, Global, EDC System - Cost Saving Scenario, 2012
  • Figure 7: eClinical Trial Solutions Market, Global, Data Quality Gap, 2012
  • Figure 8: eClinical Trial Solutions Market, Global, SaaS-based EDC System, 2012
  • Figure 9: eClinical Trial Solutions Market, Global, Cost Saving Scenario of ePRO Solutions, 2012
  • Figure 10: eClinical Trial Solutions Market, Global, Case Study of ePRO Solutions, 2012
  • Figure 11: eClinical Trial Solutions Market, Global, Case Study of ePRO Solutions, 2012
  • Figure 12: eClinical Trial Solutions Market, Global, Clinical Data Management Flow, 2012
  • Figure 13: eClinical Trial Solutions Market, Global, Clinical Trial Supply Chain Management System, 2012
  • Figure 14: eClinical Trial Solutions Market, Global, Clinical Trial Management System Market ($m), 2010-2018
  • Figure 15: eClinical Trial Solutions Market, Global, Electronic Data Capture Market ($m), 2010-2018
  • Figure 16: eClinical Trial Solutions Market, Global, Electronic Patient Reported Outcomes Market ($m), 2010-2018
  • Figure 17: eClinical Trial Solutions Market, Global, Interactive Voice Response System Market ($m), 2010-2018
  • Figure 18: eClinical Trial Solutions Market, Global, Cutting Down Clinical Trial Cost is a High Priority Task for Pharmaceutical Companies - Impact Analysis, 2012
  • Figure 19: eClinical Trial Solutions Market, Global, Research and Development Spending Split by Phases - Impact Analysis, 2012
  • Figure 20: eClinical Trial Solutions Market, Global, Adaptive Clinical Trials are Preferred by Large Biopharmaceutical Companies - Impact Analysis, 2012
  • Figure 21: eClinical Trial Solutions Market, Global, Increasing Phase III and Phase II Trials Escalates eClinical Solution Adoption - Impact Analysis, 2012
  • Figure 22: eClinical Trial Solutions Market, Global, Increasing Phase III and Phase II Trials Escalates eClinical Solution Adoption - Impact Analysis, 2012
  • Figure 23: eClinical Trial Solutions Market, Global, the Need for Improvisation of Solutions - Impact Analysis, 2012
  • Figure 24: eClinical Trial Solutions Market, Global, Research and Development Spending Split by Phases - Impact Analysis (%), 2012
  • Figure 25: eClinical Trial Solutions Market, Global, Spending on Research and Development in the US and Europe, 2004-2010
  • Figure 26: eClinical Trial Solutions Market, Global, Value of Spending in R&D by Clinical Trial Phases, 2010
  • Figure 27: eClinical Trial Solutions Market, Global, Market Potential for eClinical Trial Solutions, 2010
  • Figure 28: eClinical Trial Solutions Market, Global, Investment Trends in Future eClinical Trial Solutions, 2012
  • Figure 29: eClinical Trial Solutions Market, Global, CTMS - Technology Adoption, 2009
  • Figure 30: eClinical Trial Solutions Market, Global, Investigator Portal - Technology Adoption, 2009
  • Figure 31: eClinical Trial Solutions Market, Global, System Integration - Technology Adoption, 2009
  • Figure 32: eClinical Trial Solutions Market, Global, ePRO Solutions - Technology Adoption, 2009
  • Figure 33: eClinical Trial Solutions Market, Global, IVRS Solutions - Technology Adoption, 2009
  • Figure 34: eClinical Trial Solutions Market, Global, Factors Impacting Clinical Data Management Outsourcing - 2011
  • Figure 35: eClinical Trial Solutions Market, Global, End-to-End Services Offered by Large IT Vendors, 2011
  • Figure 36: eClinical Trial Solutions Market, Global, Supply Chain in Clinical Trials, 2011
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