Clinical Trial Management Systems (CTMS) - Global Strategic Business Report

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1 Brochure More information from Clinical Trial Management Systems (CTMS) - Global Strategic Business Report Description: This report analyzes the worldwide markets for Clinical Trial Management Systems (CTMS) in US$ Million. The report provides separate comprehensive analytics for the US, Europe, Asia-Pacific, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through Also, a six-year historic analysis is provided for these markets. The report profiles 75 companies including many key and niche players such as Aris Global, LLC, BioClinica, Inc., Bio-Optronics, Inc., DSG, Inc., eclinforce, Inc., eresearch Technology, Inc., Integrated Clinical Solutions, Inc., MedNet Solutions, Medidata Solutions, Merge eclinical, Inc., Nextrials, Inc., Oracle, Perceptive Informatics, Inc., StudyManager, Inc., Trial By Fire Solutions, LLC, Volodyne Technologies, and Winchester Business Systems. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain. Please note: Reports are sold as single-site single-user licenses. Electronic versions require hours as each copy is customized to the client with digital controls and custom watermarks. For information on site licence pricing please click on Enquire before buying Contents: CLINICAL TRIAL MANAGEMENT SYSTEMS (CTMS) A GLOBAL STRATEGIC BUSINESS REPORT CONTENTS I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS Study Reliability and Reporting Limitations I-1 Disclaimers I-2 Data Interpretation & Reporting Level I-2 Quantitative Techniques & Analytics I-3 Product Definitions and Scope of Study I-3 II. Executive Summary 1. INDUSTRY OVERVIEW II-1 Clinical Trial Management Systems (CTMS) Gain Ground II-1 Benefits Offered by CTMS II-1 Global Market Scenario II-2 Key Market Trends and Issues II-2 Clinical Trial Globalization Surges Demand for CTMS II-2 Table 1: Global Clinical Trials Market (2011): Clinical Trials Distribution by Geographic Region - Europe, North America, Asia-Pacific, Middle East & Africa and Rest of World (In %) II-3 Rising Number of Phase IV Trials Accentuates the Role of CTMS II-3 CROs - The Targeted Customers for CTMS II-4 Adaptive Trials to Alter the Design of CTMS II-4 Systems Integration Becomes Imperative II-4 CTMS Contribute to Investigator Retention II-5 Holistic Approach to Make an Impact II-5 Regulatory Compliance II-5 CDISC Standards II-5

2 Select Key Players in the CTMS Market II-6 Select Major Clinical Trial Management Systems (CTMS) Providers Worldwide II-6 2. CLINICAL TRIAL MANAGEMENT SYSTEMS - AN OVERVIEW II-7 Clinical Trial Management Systems: A Prelude II-7 CTMS Eases Clinical Trials Process II-7 Features/Benefits of a Typical CTMS II-7 Core Components of a CTMS Patient Management Solution Site Management Solutions Data Management Solution Document Management System Types of Clinical Trial Management Systems Licensed Enterprise Solution Web-Hosted Solution (CTMS SaaS) Benefits of a Web-based CTMS Technology Transfer Key Features of an Effective CTMS Major Users of CTMS II-10 Functions of CTMS II-10 For Pharma and Biotech Companies II-10 For Research Sites, Government and Academic Institutions II-10 For Contract Research Organizations II-11 Integrated CTMS Gaining Prominence II-11 Limitations of CTMS II-12 Cost and Customization II-12 Onus on Clinical Team II-12 Implementation Issues II GLOBAL CLINICAL TRIALS MARKET - A SNAPSHOT II-13 Overview II-13 Table 2: Number of Clinical Trials Worldwide: II-14 Table 3: Percentage Breakup of Number of Pipeline Drugs Worldwide by Phase-Preclinical, Phase I, Phase II, Phase III and Phase IV: 2009 Role of Contract Research Organizations in Clinical Activity Table 4: Global CRO Market (2011): Percentage Breakdown of CROs by Service Type- Phase I, Phase I-IV, Data Management Services, Regulatory Affairs, Quality Analysis, Preclinical/ Toxicology and Lab Analysis (includes corresponding II-14 II-14 Graph/Chart) II-15 China and India: Hot Spots for R&D Investment II-15 Table 5: Percentage Breakup of Global R&D Spending by Region (2011) II-16 Table 6: Percentage Breakup of Global R&D Spending by Market ( ) II-16 Table 7: Cost of Conducting Clinical Trials: India Vs US (In US$ Million) II PRODUCT INTRODUCTIONS/INNOVATIONS II-18 Forte Research Systems Introduces Allegro Research on Demand II-18 Chiltren International Releases Chiltren SAFE II-18 SIRO Clinpharm Launches "On Trak" Clinical Trial Management System II-18 Mayo Clinic Unveils Clinical Trial Software Management System II-19 Trial By Fire Solutions Rolls Out SimpleCTMS II-19 The Alzheimer s Association Launches TrialMatch II-19 BioClinica to Introduce BioClinica eclinical Technology Suite

3 and BioClinica Integrated Operations Platform II-19 Wipro Technologies Launches Wipro Rapid Trials Platform II-20 Verdacom Introduces Drug Supply Management System VerdaCore II-20 Clinilabs Introduces Clinical InSite Document Management System II-20 Fujitsu System Solutions Introduces SaaS-based tsclinical II-21 DZS Software Solutions to Unveil ClinPlus CTMS II-21 Medidata Solutions Introduces Medidata Technology Partner Program II-21 ClearTrial Releases ClearTrial v3.0 II-22 Perceptive Informatics Introduces eclinical Suite II-22 Velos Introduces Velos On-Demand II-22 TranSenda Expands Office-Smart Clinical Trial Solutions Line II PRODUCT INTRODUCTIONS/INNOVATIONS - A HISTORIC PERSPECTIVE BUILDER II-24 Perceptive Informatics Enhances TrialWorks Solution II-24 TranSenda International Introduces Office-Smart Clinical Trial Manager II-24 Actelion Pharmaceuticals and BSI Develop BSI CTMS II-24 Bio-Optronics Launches Clinical Conductor Site CTMS II RECENT INDUSTRY ACTIVITY II-26 Medidata Solutions Acquires Clinical Force II-26 Astellas Pharma Europe Chooses Perceptive s IMPACT CTMS II-26 BioClinical Acquires TranSenda International II-26 Cato Research Selects BioClinica for CTMS II-27 Novotech Selects Oracle s Siebel CTMS II-27 Oracle Acquires Phase Forward II-27 Almirall Selects Perceptive Informatics for eclinical Solutions II-27 Phase Forward and Bausch & Lomb Enters into a Multi-Year Contract II-28 Phase Forward and Gedeon Richter Ink Multi-Year Agreement II-28 Terrosa Obtains Exclusive Rights to Inclinicalperform CTMS/ SaaS Clinical Trials Collaboration Software II-28 Merge Healthcare Acquires Etrials Worldwide II-29 Veeda Oncology Selects ClinPhones TrialWorks II-29 PAREXEL International Acquires ClinPhone II-29 MacuSight Chooses etrials Worldwide for Trial Intelligence EDC and Site Intelligence IVR Solutions II-30 CFFT Therapeutics Selects Medidata Solutions for Medidata Rave II-30 Tessella Enters into Partnership with Cmed II-30 SIRO Clinpharm Successfully Implements Oracle Life Sciences Application Suite II-31 Bio-Optronics Integrates Clinical ConductorTM CTMS with RxPayingTM II-31 Mary Crowley Expands Partnership with Net.Orange II FOCUS ON SELECT PLAYERS II-33 Aris Global, LLC (US) II-33 BioClinica, Inc. (US) II-33 Bio-Optronics, Inc. (US) II-34 DSG, Inc. (US) II-34 eclinforce, Inc. (US) II-34 eresearch Technology, Inc. (US) II-35 Integrated Clinical Solutions, Inc (US) II-35 MedNet Solutions (US) II-35 Medidata Solutions (US) II-36 Merge eclinical, Inc. (US) II-36 Nextrials, Inc. (US) II-36 Oracle (US) II-36 Perceptive Informatics, Inc. (US) II-37 StudyManager, Inc. (US) II-38 Trial By Fire Solutions, LLC (US) II-38 Volodyne Technologies (India) II-38 Winchester Business Systems (US) II-38

4 8. GLOBAL MARKET PERSPECTIVE II-40 Table 8: World Recent Past, Current and Future Analysis for Clinical Trial Management Systems (CTMS) by Geographic Region- US, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart) II-40 Table 9: World Historic Review for Clinical Trial Management Systems (CTMS) by Geographic Region - US, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2003 through 2008 II-41 Table 10: World 15-Year Perspective for Clinical Trial Management Systems (CTMS) by Geographic Region - Percentage Breakdown of Revenues for US, Europe, Asia-Pacific, and Rest of World Markets for Years 2003, 2011 and 2017 (includes II-42 III. MARKET 1. THE UNITED STATES III-1 A.Market Analysis III-1 Clinical Trials Market III-1 Market Shares of Leading Players III-1 Table 11: US Market for Clinical Trial Management Systems by Leading Players (2010): Market Share Breakdown for Oracle/Phase Forward, Parexel, MediData, Nextrials, and Others III-1 FDA s 21 CFR Part 11 Compliance for CTMS III-1 Guidance for Industry Computerized Systems Used in Clinical Investigations III-2 B.Market Analytics III-3 Table 12: The US Recent Past, Current & Future Analysis for Clinical Trial Management Systems (CTMS) with Annual Revenue Figures in US$ Million for Years 2009 through 2017 III-3 Table 13: The US Historic Review for Clinical Trial Management Systems (CTMS) with Annual Revenue Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart) III-4 2. EUROPE A.Market Analysis Clinical Trials Market Focus on Select Countries Germany Russia Table 14: Russian Clinical Trials Market (2011): Percentage Breakdown by Trial Type - Global Multi-center Clinical Trials, Local Clinical Trials (Foreign Sponsors), Local Clinical Trials (Local Sponsors), Bioequivalence studies (Foreign Sponsors), and Bioequivalence Studies III-6 Table 15: Russian Clinical Trials Market (2011): Percentage Breakdown by Hosting Countries - Russia, USA, Germany, UK, Switzerland, and Others (includes III-6

5 Table 16: Number of Clinical Trials in Russia by Study Phase (2008) III-7 Table 17: Major Clinical Trial Sponsors in Russia (2008) III-7 Table 18: Top 5 Investigative Clinical Trial Sites in Russia (2008) I Spain I Garnering Investments from Multinational Pharma Companies I Phase III Clinical Trials Engross Maximum R&D Expenditure I Table 19: Apportion of R & D Expenditure by Study Phase in Spain: 2011 I B.Market Analytics III-10 Table 20: European Recent Past, Current & Future Analysis for Clinical Trial Management Systems (CTMS) with Annual Revenue Figures in US$ Million for Years 2009 through 2017 III-10 Table 21: European Historic Review for Clinical Trial Management Systems (CTMS) with Annual Revenue Figures in US$ Million for Years 2003 through 2008 (includes III ASIA-PACIFIC A.Market Analysis Asia: The Most Preferred Destination for Clinical Trials Focus on Key Markets India A Thriving Clinical Trials Market Reasons for Outsourcing to India Table 22: Cost of Conducting Clinical Trials: India Vs. US (In US$ Million) III-13 List of Pharmaceutical Companies Outsourcing Clinical Research to India III-14 India in Dire Need for Trained Investigators for Clinical Trials III-14 Challenges Faced by Indian Clinical Trials Market III-14 Outlook III-15 B.Market Analytics III-15 Table 23: Asia-Pacific Recent Past, Current & Future Analysis for Clinical Trial Management Systems (CTMS) with Annual Revenue Figures in US$ Million for Years 2009 through 2017 III-15 Table 24: Asia-Pacific Historic Review for Clinical Trial Management Systems (CTMS) with Annual Revenue Figures in US$ Million for Years 2003 through 2008 (includes III REST OF WORLD III-17 A.Market Analysis III-17 Latin America: An Emerging Market for Clinical Trials III-17 Table 25: Latin American Clinical Trials Market by Country (2011): Percentage Share Breakdown for Brazil, Mexico, Argentina, Chile, Peru, Colombia, and Others (includes III-17 B.Market Analytics III-18 Table 26: Rest of World Recent Past, Current & Future Analysis for Clinical Trial Management Systems (CTMS) with Annual Revenue Figures in US$ Million for Years 2009 through 2017 III-18

6 Table 27: Rest of World Historic Review for Clinical Trial Management Systems (CTMS) with Annual Revenue Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart) III-19 IV. COMPETITIVE LANDSCAPE Total Companies Profiled: 75 (including Divisions/Subsidiaries - 77) Region/Country Players The United States 58 Canada 4 Japan 1 Europe 8 Germany 1 The United Kingdom 4 Italy 1 Rest of Europe 2 Asia-Pacific (Excluding Japan) Ordering: Order Online - Order by Fax - using the form below Order by Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland.

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