Global Clinical Trial Management Systems (CTMS) Industry

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Global Clinical Trial Management Systems (CTMS) Industry
Published on April 2011

Report Summary

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., Clinical Force, 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 mostly extracted from URL research and reported select online sources.

Table of Content

1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS 1
Study Reliability and Reporting Limitations 1
Disclaimers 2
Data Interpretation & Reporting Level 2
Quantitative Techniques & Analytics 3
Product Definitions and Scope of Study 3

2. INDUSTRY OVERVIEW 4
Clinical Trial Management Systems (CTMS) Gain Ground 4
Benefits Offered by CTMS 4
Global Market Scenario 4
Key Market Trends and Issues 5
Clinical Trial Globalization Surges Demand for CTMS 5
Table 1: Global Clinical Trials Market (2006 & 2010):
Clinical Trials Distribution by Geographic Region - Europe,
North America, Asia-Pacific, Middle East & Africa and Rest
of World (In %) (includes corresponding Graph/Chart) 6
Rising Number of Phase IV Trials Accentuates the Role of CTMS 6
CROs - The Targeted Customers for CTMS 7
Adaptive Trials to Alter the Design of CTMS 7
Systems Integration Becomes Imperative 8
CTMS Contribute to Investigator Retention 8
Holistic Approach to Make an Impact 8

Global Clinical Trial Management Systems (CTMS) Industry (From Slideshare) Page 1/9


Regulatory Compliance 9
CDISC Standards 9
Select Key Players in the CTMS Market 9
Select Major Clinical Trial Management Systems (CTMS)
Providers Worldwide 10

3. CLINICAL TRIAL MANAGEMENT SYSTEMS - AN OVERVIEW 11
Clinical Trial Management Systems: A Prelude 11
CTMS Eases Clinical Trials Process 11
Features/Benefits of a Typical CTMS 11
Core Components of a CTMS 12
Patient Management Solution 12
Site Management Solutions 12
Data Management Solution 12
Document Management System 12
Types of Clinical Trial Management Systems 12
Licensed Enterprise Solution 13
Web-Hosted Solution (CTMS SaaS) 13
Benefits of a Web-based CTMS 13
Technology Transfer 13
Key Features of an Effective CTMS 13
Major Users of CTMS 14
Functions of CTMS 14
For Pharma and Biotech Companies 14
For Research Sites, Government and Academic Institutions 14
For Contract Research Organizations 15
Integrated CTMS Gaining Prominence 15
Limitations of CTMS 16
Cost and Customization 16
Onus on Clinical Team 16
Implementation Issues 16

4. GLOBAL CLINICAL TRIALS MARKET - A SNAPSHOT 17
Overview 17
Table 2: Number of Clinical Trials Worldwide: 2000-2009
(includes corresponding Graph/Chart) 18

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) 18
Role of Contract Research Organizations in Clinical Activity 18
Table 4: Global CRO Market (2007): Number 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) 19
China and India: Hot Spots for R&D Investment 19
Table 5: Percentage Breakup of Global R&D Spending by Region



(2009) (includes corresponding Graph/Chart) 20
Table 6: Percentage Breakup of Global R&D Spending by Market
(2005-2010) (includes corresponding Graph/Chart) 20

Table 7: Cost of Conducting Clinical Trials: India Vs. US (In
US$ Million) (includes corresponding Graph/Chart) 20

5. PRODUCT INTRODUCTIONS/LAUNCHES 21
Forte Research Systems Introduces Allegro' Research on Demand 21
Chiltren International Releases Chiltren SAFE 21
SIRO Clinpharm Launches "On Trak" Clinical Trial Management
System 21
Mayo Clinic Unveils Clinical Trial Software Management System 22
Trial By Fire Solutions Rolls Out SimpleCTMS 22
The Alzheimer's Association Launches TrialMatch 22
BioClinica' to Introduce BioClinica eClinical Technology Suite
and BioClinica Integrated Operations Platform 22
Wipro Technologies Launches Wipro Rapid Trials Platform 23
Verdacom Introduces Drug Supply Management System VerdaCore 23
Clinilabs Introduces Clinical InSite Document Management System 23
Fujitsu System Solutions Introduces SaaS-based tsClinical 24
DZS Software Solutions to Unveil ClinPlus® CTMS 24
Medidata Solutions Introduces Medidata Technology Partner Program 24
ClearTrial Releases ClearTrial v3.0 25
Perceptive Informatics Introduces eClinical Suite 25
Velos Introduces Velos On-Demand 25
TranSenda Expands Office-Smart Clinical Trial Solutions Line 26
Perceptive Informatics Enhances TrialWorks® Solution 26
TranSenda International Introduces Office-Smart Clinical Trial
Manager 27
Actelion Pharmaceuticals and BSI Develop BSI CTMS 27
Bio-Optronics Launches Clinical Conductor Site CTMS 28

6. RECENT INDUSTRY ACTIVITY 29
Astellas Pharma Europe Chooses Perceptive's IMPACT' CTMS 29
BioClinical Acquires TranSenda International 29
Cato Research Selects BioClinica for CTMS 29
Novotech Selects Oracle's Siebel CTMS 29
Oracle Acquires Phase Forward 30
Almirall Selects Perceptive Informatics for eClinical Solutions 30
Phase Forward and Bausch & Lomb Enters into a Multi-Year Contract 31
Phase Forward and Gedeon Richter Ink Multi-Year Agreement 31
Terrosa Obtains Exclusive Rights to Inclinicalperform CTMS/
SaaS Clinical Trials Collaboration Software 31
Merge Healthcare Acquires Etrials Worldwide 31
Veeda Oncology Selects ClinPhone's TrialWorks® 32
PAREXEL International Acquires ClinPhone 32
MacuSight Chooses etrials Worldwide for Trial Intelligence EDC



and Site Intelligence IVR Solutions 32
CFFT Therapeutics Selects Medidata Solutions for Medidata Rave® 33
Tessella Enters into Partnership with Cmed 33
SIRO Clinpharm Successfully Implements Oracle Life Sciences
Application Suite 33
Bio-Optronics Integrates Clinical ConductorTM CTMS with
RxPayingTM 34
Mary Crowley Expands Partnership with Net.Orange 34

7. FOCUS ON SELECT PLAYERS 35
Aris Global, LLC (US) 35
BioClinica, Inc. (US) 35
Bio-Optronics, Inc. (US) 36
Clinical Force, Inc. (US) 36
DSG, Inc. (US) 36
eClinForce, Inc. (US) 37
eResearch Technology, Inc. (US) 37
Integrated Clinical Solutions, Inc (US) 37
MedNet Solutions (US) 37
Medidata Solutions (US) 38
Merge eClinical, Inc. (US) 38
Nextrials, Inc. (US) 39
Oracle (US) 39
Perceptive Informatics, Inc. (US) 40
StudyManager, Inc. (US) 40
Trial By Fire Solutions, LLC (US) 40
Volodyne Technologies (India) 41
Winchester Business Systems (US) 41

8. GLOBAL MARKET PERSPECTIVE 42
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) 42

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) 43

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, 2010 and 2017 (includes
corresponding Graph/Chart) 44



9. THE UNITED STATES 45
A.Market Analysis 45
Current and Future Analysis 45
Clinical Trials Market in the US 45
Market Shares of Leading Players 45
Table 11: US Market for Clinical Trial Management Systems
by Leading Players (2009): Market Share Breakdown for
Oracle, Phase Forward, Parexel, MediData, Nextrials, and
Others (includes corresponding Graph/Chart) 45
FDA's 21 CFR Part 11 Compliance for CTMS 46
Guidance for Industry Computerized Systems Used in Clinical
Investigations 46
B.Market Analytics 47
Table 12: US Recent Past, Current & Future Analysis for
Clinical Trial Management Systems (CTMS) - Annual Revenue
Figures in US$ Million for Years 2009 through 2017 (includes

Table 13: US Historic Review for Clinical Trial Management
Systems (CTMS) - Annual Revenue Figures in US$ Million for
Years 2003 through 2008 (includes corresponding Graph/Chart) 47

10. EUROPE 48
Outlook 48
Clinical Trials Market in Europe 48
Focus on Select Countries 48
Germany 48
Russia 49
Table 14: Russian Clinical Trials Market (2009):
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

Table 15: Russian Clinical Trials Market (2008):
Percentage Breakdown by Hosting Countries - Russia, USA,
Germany, UK, Switzerland, and Others (includes

Table 16: Number of Clinical Trials in Russia by Study
Phase (2008) (includes corresponding Graph/Chart) 50

Table 17: Major Clinical Trial Sponsors in Russia (2008)

Table 18: Top 5 Investigative Clinical Trial Sites in



Russia (2008) (includes corresponding Graph/Chart) 51
Spain 51
Garnering Investments from Multinational Pharma Companies 51
Phase III Clinical Trials Engross Maximum R&D Expenditure 51
Table 19: Apportion of R & D Expenditure by Study Phase
in Spain: 2008 (includes corresponding Graph/Chart) 52
Table 20: European Recent Past, Current & Future Analysis
for Clinical Trial Management Systems (CTMS) - Annual
Revenue Figures in US$ Million for Years 2009 through 2017

Table 21: European Historic Review for Clinical Trial
Management Systems (CTMS) - Annual Revenue Figures in US$
Graph/Chart) 53

11. ASIA-PACIFIC 54
Asia: The Most Preferred Destination for Clinical Trials 54
Focus on Key Markets 54
India 54
A Thriving Clinical Trials Market 54
Reasons for Outsourcing to India 55
Table 22: Cost of Conducting Clinical Trials: India Vs.
US (In US$ Million) (includes corresponding Graph/Chart) 55
List of Pharmaceutical Companies Outsourcing Clinical
Research to India 56
India in Dire Need for Trained Investigators for Clinical
Trials 56
Challenges Faced by Indian Clinical Trials Market 56
Outlook 57
Table 23: Asia-Pacific Recent Past, Current & Future
Analysis for Clinical Trial Management Systems (CTMS) -
Annual Revenue Figures in US$ Million for Years 2009 through
2017 (includes corresponding Graph/Chart) 57

Table 24: Asia-Pacific Historic Review for Clinical Trial
Management Systems (CTMS) - Annual Revenue Figures in US$
Graph/Chart) 58

12. REST OF THE WORLD 59
Latin America: An Emerging Market for Clinical Trials 59
Table 25: Latin American Clinical Trials Market by Country
(2009): Percentage Share Breakdown for Brazil, Mexico,



Argentina, Chile, Peru, Colombia, Costa Rica, Guatemala,
and Panama (includes corresponding Graph/Chart) 59
Table 26: Rest of the World Recent Past, Current & Future
Analysis for Clinical Trial Management Systems (CTMS) -
Annual Revenue Figures in US$ Million for Years 2009 through
2017 (includes corresponding Graph/Chart) 60

Table 27: Rest of the World Historic Review for Clinical
Trial Management Systems (CTMS) - Annual Revenue Figures in
US$ Million for Years 2003 through 2008 (includes

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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