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

Global Industry Analysts, Inc, April 2012, Pages: 414

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.

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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 %) (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 R&D Investment II-15
Table 5: Percentage Breakup of Global R&D Spending by Region
(2011) (includes corresponding Graph/Chart) II-16

Table 6: Percentage Breakup of Global R&D 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 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
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 & 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-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 & 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 R&D Expenditure III-9
Table 19: Apportion of R & 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 & 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 & 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 & 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
------------------------------------------

As the drug development process globalizes due to increased outsourcing, and the process becomes more complex and larger compelled by the Phase IV or post-marketing studies, companies are extensively adopting electronic technologies, which are transforming the way clinical trials are being conducted. Over the years, several e-clinical technologies have been launched, which include 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. Clinical Trial Management Systems (CTMS) is fast emerging as one of the key options for drug developers to achieve process efficiencies. Besides efficiency, several other issues that are driving the market for CTMS include growing complexity of trials, increased focus on accuracy and costs.

Clinical Trial Management Systems (CTMS) constitute a large market, and is witnessing robust growth in the backdrop of challenging market environment for the pharmaceutical industry. Faced with concerns such as narrowing drug development pipeline and increased costs as well as the need for regulatory compliance, drug developers, the world over, are scouting for ways to bring down drug development costs by enhancing overall efficiency. Clinical trial management systems are offered as a licensed, hosted, or SaaS-based solution. Features, compliance, functionality, security, and price are key determinants in selecting a CTMS. Several companies are expected to adopt subscription services in the ensuing years. The market is also likely to witness increased innovations, as more and more companies are expected to allocate additional budgets for innovations that would lead to improved regulatory compliance, and enable companies in realizing savings of about US$10 to US$12 million annually.

The US represents the largest regional market for clinical trial management systems (CTMS) worldwide, as stated by the new market research report on Clinical Trial Management Systems (CTMS). The US exhibits huge untapped potential, as several clinical trial sites in the country still use traditional means for managing trials. Organizations such as National Cancer Institute (NCI) are further pushing the increased adoption of clinical trial management systems, facilitating the sharing of data with minimal errors, at reduced cost, and in a more organized manner. Europe trails behind the US, with the two markets together accounting for a lion’s share of the global CTMS market. However, growth in the market would be led by Asia-Pacific, which is projected to be the fastest growing regional market during the analysis period. Asia-Pacific market for CTMS is projected to post a compounded annual growth rate of about 14.4% during the analysis period.

One of the key emerging trends in the global pharmaceutical industry over the recent years is the rising number of post-marketing studies or Phase IV studies. As many as 75% of drugs that received approval during the period 1998-2008 in Europe and the US were associated with commitments to carry out post-marketing studies. About half of the drugs approved in Japan were also subjected to similar commitments. These studies are generally larger involving thousands of patients and clinical sites, which render specific challenges. Clinical Trial Management Systems (CTMS) find significant application in these studies, owing to built-in workflows in these systems that enable easy implementation and modification for addressing unique challenges of these arduous studies. Another trend in the market is the integration of CTMS with other systems. Vendors of standard-based open architecture are providing substantial assistance to biopharmaceutical companies in the area of integrating such systems. Service-oriented architecture provides a common platform that can be used in building solutions as interoperable services. Companies such as Oracle are developing advanced applications based on service-oriented architecture for the clinical trial industry.

Major players profiled in the report include 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., Winchester Business Systems, among others.

The research report titled “Clinical Trial Management Systems (CTMS): A Global Strategic Business Report” announced by Global Industry Analysts Inc., provides a comprehensive review of the clinical trial management systems market, current market trends, key growth drivers, recent product introductions, recent industry activity, and profiles of major/niche global as well as regional market participants. The report provides annual sales estimates and projections for clinical trial management systems market for the years 2009 through 2017 for the following geographic markets - US, Europe, Asia-Pacific, and Rest of World. Also, a six-year (2003-2008) historic analysis is provided for additional perspective.

© Global Industry Analysts

- Aris Global, LLC (US)
- BioClinica, Inc. (US)
- Bio-Optronics, Inc. (US)
- Clinical Force, Inc. (US)
- DSG, Inc. (US)
- eClinForce, Inc. (US)
- eResearch Technology, Inc. (US)
- Integrated Clinical Solutions, Inc (US)
- MedNet Solutions (US)
- Medidata Solutions (US)
- Merge eClinical, Inc. (US)
- Nextrials, Inc. (US)
- Oracle (US)
- Perceptive Informatics, Inc. (US)
- StudyManager, Inc. (US)
- Trial By Fire Solutions, LLC (US)
- Volodyne Technologies (India)
- Winchester Business Systems (US)

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