Global Clinical Trial Management Systems (CTMS) Industry

  • April 2012
  • -
  • Global Industry Analysts
  • -
  • 414 pages

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 2017. 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.

Table Of Contents




I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-2
Quantitative Techniques and 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 and Africa and Rest of
World (In %) (includes corresponding Graph/Chart) 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
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 II-8
Patient Management Solution II-8
Site Management Solutions II-8
Data Management Solution II-8
Document Management System II-8
Types of Clinical Trial Management Systems II-8
Licensed Enterprise Solution II-9
Web-Hosted Solution (CTMS SaaS) II-9
Benefits of a Web-based CTMS II-9
Technology Transfer II-9
Key Features of an Effective CTMS II-9
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-12

3. GLOBAL CLINICAL TRIALS MARKET - A SNAPSHOT II-13
Overview II-13
Table 2: Number of Clinical Trials Worldwide: 2000-2009
(includes corresponding Graph/Chart) 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 (includes corresponding Graph/Chart) II-14
Role of Contract Research Organizations in Clinical Activity II-14
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
Graph/Chart) II-15
China and India: Hot Spots for RandD Investment II-15
Table 5: Percentage Breakup of Global RandD Spending by Region
(2011) (includes corresponding Graph/Chart) II-16

Table 6: Percentage Breakup of Global RandD Spending by Market
(2005-2011) (includes corresponding Graph/Chart) II-16

Table 7: Cost of Conducting Clinical Trials: India Vs US (In
US$ Million) (includes corresponding Graph/Chart) II-17

4. PRODUCT INTRODUCTIONS/INNOVATIONS II-18
Forte Research Systems Introduces Allegroâ„¢ 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
BioClinicaâ„¢ to Introduce BioClinica eClinical Technology Suite
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-23

5. 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-25

6. 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 and 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 ClinPhone's 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-32

7. 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

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 (includes corresponding Graph/Chart) 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
corresponding Graph/Chart) 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 (includes corresponding Graph/Chart) 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 and Future Analysis for
Clinical Trial Management Systems (CTMS) with Annual Revenue
Figures in US$ Million for Years 2009 through 2017
(includes corresponding Graph/Chart) 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 III-5
A.Market Analysis III-5
Clinical Trials Market III-5
Focus on Select Countries III-5
Germany III-5
Russia III-5
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
(includes corresponding Graph/Chart) III-6

Table 15: Russian Clinical Trials Market (2011):
Percentage Breakdown by Hosting Countries - Russia, USA,
Germany, UK, Switzerland, and Others (includes
corresponding Graph/Chart) III-6

Table 16: Number of Clinical Trials in Russia by Study
Phase (2008) (includes corresponding Graph/Chart) III-7

Table 17: Major Clinical Trial Sponsors in Russia (2008)
(includes corresponding Graph/Chart) III-7

Table 18: Top 5 Investigative Clinical Trial Sites in
Russia (2008) (includes corresponding Graph/Chart) III-8
Spain III-8
Garnering Investments from Multinational Pharma Companies III-8
Phase III Clinical Trials Engross Maximum RandD Expenditure III-9
Table 19: Apportion of R and D Expenditure by Study Phase
in Spain: 2011 (includes corresponding Graph/Chart) III-9
B.Market Analytics III-10
Table 20: European Recent Past, Current and Future Analysis
for Clinical Trial Management Systems (CTMS) with Annual
Revenue Figures in US$ Million for Years 2009 through 2017
(includes corresponding Graph/Chart) 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
corresponding Graph/Chart) III-11

3. ASIA-PACIFIC III-12
A.Market Analysis III-12
Asia: The Most Preferred Destination for Clinical Trials III-12
Focus on Key Markets III-12
India III-12
A Thriving Clinical Trials Market III-12
Reasons for Outsourcing to India III-12
Table 22: Cost of Conducting Clinical Trials: India Vs.
US (In US$ Million) (includes corresponding Graph/Chart) 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 and Future
Analysis for Clinical Trial Management Systems (CTMS) with
Annual Revenue Figures in US$ Million for Years 2009
through 2017 (includes corresponding Graph/Chart) 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
corresponding Graph/Chart) III-16

4. 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
corresponding Graph/Chart) III-17
B.Market Analytics III-18
Table 26: Rest of World Recent Past, Current and Future
Analysis for Clinical Trial Management Systems (CTMS) with
Annual Revenue Figures in US$ Million for Years 2009
through 2017 (includes corresponding Graph/Chart) III-18

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) 6
------------------------------------------

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