World E-Clinical Trial Technologies Industry

  • January 2015
  • -
  • Global Industry Analysts
  • -
  • 288 pages

This report analyzes the worldwide markets for E-Clinical Trial Technologies in US$ Million by the following Segments: Electronic Data Capture (EDC) Solutions, Clinical Trial Management System (CTMS), Electronic Patient Reported Outcome (ePRO), and Randomization and Trial Supply Management (RTSM). The report provides separate comprehensive analytics for the US, Canada, Europe, Asia-Pacific, and Rest of World. Annual estimates and forecasts are provided for the period 2013 through 2020. Also, a three-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 85 companies including many key and niche players such as -

Almac Group
ArisGlobal LLC
BioClinica
Clinipace Worldwide
Cmed Technology Ltd.

Table Of Contents

World E-Clinical Trial Technologies Industry



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
Electronic Data Capture (EDC) Solutions I-3
Clinical Trial Management System (CTMS) I-4
Electronic Patient Reported Outcome (ePRO) I-4
Randomization and Trial Supply Management (RTSM) I-4


II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
A Prelude II-1
Impact of Healthcare Budget Cuts: A Retrospective Review II-1
Table 1: Healthcare Spending as a Percentage of GDP in Select
Countries (includes corresponding Graph/Chart) II-2
Table 2: Global Pharma and Biotech RandD Spending by Sector: 2014
(includes corresponding Graph/Chart) II-2
Market Outlook II-3
Table 3: World E-Clinical Trial Technologies Market (2014):
Revenues in USD Million by Major Segment (includes
corresponding Graph/Chart) II-4
Market Gravitates from Developed Countries to Developing
Countries II-4
Outsourcing of Clinical Studies to Developing Countries
Benefits Market II-6
Globalization Boosts e-Clinical Trials Market II-6
Table 4: Global Clinical Trials Market (2014): 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-6

Table 5: Comparison of Clinical Trial Costs between India
and US by Trial Phase (includes corresponding Graph/Chart) II-7
Regulatory Acceptance of Electronic Submissions: An Important
Growth Driver II-7
Cost-Containment: An Important Factor Increasing the Uptake of
E-Clinical Trial Technologies II-7
Sponsor Consolidation Brings forth the Risk of Competition II-8
Governmental Regulations Risk the Requirement of Costly
Modifications to Technology II-8

2. MARKET DYNAMICS II-9
EDC Segment Witnesses Upward Trend II-9
Factors influencing EDC Selection II-10
Vendors Track Record II-10
Regulatory Compliance II-10
Data Security Standards II-10
Product and Service Prices II-10
Tablet-format Data Capture Devices to Gain Traction in the EDC
Market II-11
Tangible Cost -savings Bolster Rapid Uptake of CTMS Solutions II-12
Select Major Clinical Trial Management Systems (CTMS)
Providers Worldwide II-13
Rising Number of Phase IV Trials Accentuates Role of CTMS II-13
Electronic Patient Record (ePRO) Solutions Fast Replacing
Paper-Based PRO systems II-13
Preference Grows for Customized/Configured RTSM II-14
RTSM Systems with Self-Service Capabilities to Displace
Traditional IVR/IWR Software II-14
Multifarious Operational Benefits Drive IVRS Adoption II-15
Globalization of Clinical Trials Throws Up Challenges for
IVR/IWR System Developers II-15
Integration of Standalone eClinical Systems: Need of the Hour II-16
Growing Call for Integration of EDC with CTMS and ePRO Systems II-17
Integrated EDC-RTSM Systems - the New Paradigm II-17
Next Generation e-Clinical Systems Help Life Sciences
Companies Face New Challenges II-18
Open Source - Emerging Solutions in Clinical Trials Domain II-19
Select Open Source Technologies for Clinical Trials by
Application Area II-20
Benefits over Proprietary Technologies to Encourage Adoption II-20
EDC- The Most Attractive Application for Open Source II-20
Conversion to CDISC - An Emerging Application for Open Source
Solutions II-20
Mobile Technologies to Help Trial Operators in Tackling
Challenges II-21
Table 6: World Smartphone Penetration for Select Countries
(as a Percentage of Mobile Phone Users): 2013 (includes
corresponding Graph/Chart) II-21

Table 7: Worldwide Mobile Networks (2013 and 2018): Percentage
Share Breakdown of Number of Connections by Type of Network
Technology (includes corresponding Graph/Chart) II-22
Smartphones and Tablets: The New Age ePRO Devices II-23
Surging SaaS-Based Solutions in the eClinical Landscape II-24
Web-based Tools for Enrolment Modeling and Planning II-25
A Peek into Other Innovative Technologies II-25
Software Solutions for Capacity Planning and Forecasting -
a Noteworthy Technology in the Offing II-26

3. COMPETITIVE LANDSCAPE II-27
Oracle Dominates the eClinical Trial Solutions Space II-27
Table 8: Leading Players in the Global E-Clinical Market
(2011): Percentage Breakdown of Revenues for Oracle/Phase
Forward, Medidata, Perceptive, and Others
(includes corresponding Graph/Chart) II-28
Select Leading Players in eClinical Technologies II-28
Oracle's Acquisition Spree Heats up Competition II-29
Competition in EDC Market: An Insight II-29
A Fragmented Industry II-29
Table 9: Global EDC Market by Leading Player (2013): Market
Share Breakdown for Medidata, Oracle, and Others
(includes corresponding Graph/Chart) II-29
Competitive Factors II-29
Select Key Players in the CTMS Market II-30
Snapshot of Select CTMS Solutions II-30

4. PRODUCT PROFILE II-31
Defining E-Clinical Trials II-31
Benefits Offered by E-Clinical Trials II-31
Transparency II-31
Dynamic Program Management II-32
Effective Trial Drug Supply II-32
Effective Study Randomization II-32
Enhanced Collaboration II-32
Dynamic Site Management II-32
Less Frequent Investigational Site Visits II-32
Faster Go No-Go Decisions II-32
Better Planning II-32
Regulatory Compliance II-33
CDISC Standards II-33
Clinical Trials- In a Nutshell II-33
Summarization of Clinical Trial Phases and Time Line for Drug
Development II-33
Systems Used in E-Clinical Trials II-34
Electronic Data Capture Solutions (EDC) II-34
Benefits of EDC II-34
EDC and Paper CRFs - A Comparison II-34
Recent Advancements in EDC II-35
Clinical Trial Management System (CTMS) II-36
CDMS to CTMS: The Evolutionary Move to eDevelopment II-36
CROs - The Targeted Customers for CTMS II-37
Clinical Trial Image Management System (CTMS) II-37
Electronic Patient Reported Outcome (ePRO) II-37
Electronic Diaries II-38
Randomization and Trial Supply Management (RTSM) II-38
Interactive Voice Response Systems (IVRS) II-38
Technologies Used in IVR II-39
Interactive Web Response Systems (IWRS) II-40

5. PRODUCT/SERVICE INTRODUCTIONS II-41
Parexel Releases Latest Version of ClinPhone RTSM II-41
OmniComm Release of TrialOne Version 4.3 II-41
Techorizon Launches Th-eClinical II-41
ArisGlobal Releases agCapture version 3.2 II-41
ArisGlobal Unveils agVet Pharmacovigilance Solution II-41
Surrey Clinical Research Centre Inks 5-year Contract for
OmniComm's Promasys II-41
PHT Corporation Introduces LogPad® System on Google Nexus
Smartphone II-42
ArisGlobal Introduces agInquirer 3.1 II-42
eClinical Insights Unveils eClinical Intelligence Platform II-42
OmniComm Systems, Inc. Introduces TrialMaster EDC Version 4.2 II-42
Perceptive Introduces Enhanced Version of IMPACT® CTMS Solution II-42
CluePoint Unveils SMART Engine Risk-Based Monitoring Solution II-42
ArisGlobal Introduces agDisclosure 3.1 Solution II-42
Clinipace Worldwide Improves TEMPO eClinical Platform II-43
Phoenix Software International Unveils Entrypoint i4 EDC Software II-43
CRF Health Unveils TrialMax® Suite eCOA Software with Android
Support II-43
OpenClinica Unveils Version 3.1.3 of OpenClinica Enterprise
Edition II-43
ePharmaSolutions Introduces PatientLive App for Windows 8
Platform II-43
Forte Research Incorporates Submission Console in OnCore® CRMS II-43
Veeva Systems Introduces Vault eTMF Cloud-Based Application II-43
MedNet Solutions Introduces New Version of iMedNet EDC
Application II-44
Michigan Institute Unveils Mi-OC Version of OpenClinica CTMS II-44
MonitorForHire.com Unveils New Mobile-Based Application II-44
PHT Introduces NetPRO 1.3 Solution II-44
ERT Unveils Upgraded Clinical Research Workflow Technology II-44
Anoto Group, Ubisys and Perinatal Institute Develop E-Preginfo
Maternity EDC System II-44
Formedix Releases Transform Suite for Perceptive's DataLabs
EDC Systems II-44
OmniComm Systems Unveils TrialMaster Version 4.1.2 II-44
Techsol Introduces QuickLaunch LabPas Deployment Package II-45
Syne Qua Non Unveils New Version of Syne-clin® System II-45
PAREXEL International Introduces PAREXEL MyTrials Platform II-45
Merge Healthcare Rolls Out Merge eClinical OS II-45
Y-Prime Technologies Introduces Prime Publisher Concatenation
Tool II-45
Nextrials to Unveil iPad Application for Prism Clinical Trial
Management Platform II-45
IMS Health Introduces IMS SiteOptimizer II-45
Forte Research Systems Introduces OnCore® Version 12.0 CRMS II-45
MedPoint Digital Launches Mobile Friendly eClinical Technologies II-46
Lilly Oncology Introduces Clinical Trial Resource Mobile
Application II-46
PharmaPros Unveils Adapt Central Hybrid Solution II-46
PHT Launches Version 4.16 of StudyWorks II-46
Perceptive Informatics Unveils Site Inventory Management
Module for ClinPhone RTSM II-46
Oracle Health Sciences Unveils New Version of Clinical
Development Analytics II-46
Y-Prime Technologies Rolls Out Prime IxR and Prime eMVR Systems II-46
Trianz Solutions Unveils Acceliant eClinical Suite-v6.4 II-46
Forte Research Systems Unveils New Version of Allegro CTMS@Site II-47
DATATRAK International Unveils uCTMS Clinical Trial Management
System II-47
Synteract Launches SynCaptureâ„¢ EDC System in Version 1.5 II-47

6. RECENT INDUSTRY ACTIVITY II-48
BioClinica Takes Over Blueprint Clinical, Inc. II-48
Cliantha Research Takes Over Karmic Lifesciences II-48
Eurotrials Partners Merge eClinical for Clinical Research
Technology II-48
Instem and Medidata Solutions to Integrate Medidata Rave and
ALPHADAS II-48
Clinverse Partners with eClinical Insights II-48
TFS International Selects OmniComm TrialMaster II-48
JLL Partners Takes Over CoreLab Partners and BioClinica II-49
CROS NT Takes Over Symphony EDC System from Powertrial II-49
PharmaPros Renamed as eClinical Insights II-49
SGS Life Science Services Selects Merge eCLINICAL OSâ„¢ for
Phase I-IV Studies II-49
Tampa General Hospital Adopts Merge Healthcare CTMS II-49
SIRO Clinpharm Deploys Oracle Health Sciences InForm II-49
OmniComm Systems Partners Soltex Consulting II-50
Oracle Takes Over ClearTrial II-50
Clinipace Worldwide Merges with Paragon Biomedical to Acquire
Irvine II-50
eResearch Technology Acquires Invivodata II-50
IMS Health Takes Over DecisionView II-50
NTT Data Secures DATATRAK Non-Exclusive License for Reselling
DATATRAK ONE II-50
Larix Signs Agreement with OmniComm Systems for eClinical Suite II-50
QED Clinical Services Selects SimpleCTMS for Trial By Fire
Solutions II-50
Veeva Systems and Medidata Solutions Collaborate for
Integrated Vault eTMF Solution II-51
NextDocs and BioClinica Enter into Partnership II-51
Merge Healthcare and AG Mednet Enter into Partnership II-51
Eclinso and XClinical Ink Strategic Partnership Agreement II-51
NCGS Chooses Merge Healthcare's eClinical OS and CTMS II-51
Worldwide Clinical Trials Selects TransPerfect eTMF II-51
TauRx Therapeutics Inks Agreements with BioClinica II-51
Advanced Clinical Joins iMedNetâ„¢ Partner Program of MedNet
Solutions II-52
Tigermed Consulting Chooses Merge Healthcare CTMS II-52
Datapharm Australia Chooses Merge Healthcare's eClinical OS II-52
Kaketsuken Deploys Medidata Solutions' Rave® and Balance RTMS II-52
Sanofi Selects BioClinica OnPoint CTMS II-52
Isis Pharmaceuticals to Extend Use of BioClinica's Express EDC
for Upcoming Trials II-52
Worldwide Clinical Trials Chooses eClinical OSâ„¢ System from
Merge Healthcare II-52
TFS International Deploys Medidata CTMS from Medidata
Solutions Worldwide II-52
Luitpold Pharmaceuticals Selects Express EDC from BioClinic II-53
Cytochroma Chooses Suite of Applications from Systems II-53
TriReme Medical Chooses OpenClinica Enterprise Edition II-53
UCL Clinical Trials Unit Selects MACRO EDC Solution from InferMed II-53
CHDI Foundation to Deploy eClinical GPS Platform and ClinCard
System II-53
INC Research Chooses Trial Interactive eTMF from TransPerfect II-53
PRC Clinical Selects SimpleCTMS from Trial By Fire Solutions II-53
TKL Research Selects Medidata CTMS II-53
Grünenthal Inks License Agreement with BioClinica II-54
Amarin Selects eClinical Suite of BioClinica II-54
OmniComm Systems Secures License for Pharma Medica's
TrialMaster Suite II-54
Harrison Clinical Research Chooses BioClinica OnPoint CTMS II-54
Greenphire Enters into Strategic Partnership with Merge
Healthcare II-54

7. FOCUS ON SELECT PLAYERS II-55
Almac Group (UK) II-55
ArisGlobal LLC (US) II-55
BioClinica (US) II-56
Clinipace Worldwide (US) II-57
Cmed Technology Ltd (UK) II-57
DATATRAK International, Inc. (US) II-58
DSG Inc. (US) II-58
DZS Software Solutions, Inc. (US) II-59
eClinForce, Inc (US) II-60
eClinical Insights, Inc. (US) II-60
eResearch Technology, Inc. (US) II-61
Integrated Clinical Solutions, Inc. (US) II-61
Medidata Solutions, Inc. (US) II-62
MedNet Solutions (US) II-62
Merge Healthcare, Inc. (US) II-63
Nextrials Inc. (US) II-64
OmniComm Systems, Inc. (US) II-64
Oracle Health Sciences (US) II-64
PAREXEL International Corp. (US) II-65
Perceptive Informatics, Inc. (US) II-66
PHT Corp. (US) II-66
Prelude Dynamics LLC (US) II-67
SAS Institute Inc. (US) II-67
Target Health Inc. (US) II-67
Trianz Solutions (US) II-68

8. GLOBAL MARKET PERSPECTIVE II-69
Table 10: World Recent Past, Current and Future Analysis for
E-Clinical Trial Technologies Market by Geographic Region -
US, Canada, Europe, Asia-Pacific (Including Japan), and Rest
of World Markets Independently Analyzed with Annual Revenue
Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) II-69

Table 11: World Historic Review for E-Clinical Trial
Technologies Market by Geographic Region - US, Canada, Europe,
Asia-Pacific (Including Japan), and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2010 through 2012
(includes corresponding Graph/Chart) II-70

Table 12: World 11-Year Perspective for E-Clinical Trial
Technologies Market by Geographic Region - Percentage
Breakdown of Dollar Revenues for US, Canada, Europe,
Asia-Pacific (Including Japan), and Rest of World Markets for
Years 2010, 2014 and 2020 (includes corresponding Graph/Chart) II-71

Table 13: World Recent Past, Current and Future Analysis for
E-Clinical Trial Technologies Market by Application - EDC,
CTMS, ePROs, and RTSM Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2013 through
2020 (includes corresponding Graph/Chart) II-72

Table 14: World Historic Review for E-Clinical Trial
Technologies Market by Application - EDC, CTMS, ePROs, and
RTSM Markets Independently Analyzed with Annual Revenue
Figures in US$ Million for Years 2010 through 2012
(includes corresponding Graph/Chart) II-73

Table 15: World 11-Year Perspective for E-Clinical Trial
Technologies Market by Application - Percentage Breakdown of
Dollar Revenues for EDC, CTMS, ePROs, and RTSM Markets for
Years 2010, 2014 and 2020 (includes corresponding Graph/Chart) II-74

Table 16: World Recent Past, Current and Future Analysis for
Electronic Data Capture (EDC) Market by Clinical Trial Phase -
Phase I, II, III, and IV Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2013 through
2020 (includes corresponding Graph/Chart) II-75

Table 17: World Historic Review for Electronic Data Capture
(EDC) Market by Clinical Trial Phase - Phase I, II, III, and
IV Markets Independently Analyzed with Annual Revenue Figures
in US$ Million for Years 2010 through 2012 (includes
corresponding Graph/Chart) II-76

Table 18: World 11-Year Perspective for Electronic Data
Capture (EDC) Market by Clinical Trial Phase - Percentage
Breakdown of Dollar Revenues for Phase I, II, III, and IV
Markets for Years 2010, 2014 and 2020 (includes corresponding
Graph/Chart) II-77

Table 19: World Recent Past, Current and Future Analysis for
Clinical Trial Management Systems (CTMS) Market by Delivery
Mode - Web-based CTMS, Cloud-based CTMS and On-Premise CTMS
Markets Independently Analyzed with Annual Revenue Figures in
US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) II-78

Table 20: World Historic Review for Clinical Trial Management
Systems (CTMS) Market by Delivery Mode - Web-based CTMS,
Cloud-based CTMS and On-Premise CTMS Markets Independently
Analyzed with Annual Revenue Figures in US$ Million for Years
2010 through 2012 (includes corresponding Graph/Chart) II-79

Table 21: World 11-Year Perspective for Clinical Trial
Management Systems (CTMS) Market by Delivery Mode - Percentage
Breakdown of Dollar Revenues for Web-based CTMS, Cloud-based
CTMS and On-Premise CTMS Markets for Years 2010, 2014 and 2020
(includes corresponding Graph/Chart) II-80

Table 22: World Recent Past, Current and Future Analysis for
Electronic Patient Reported Outcomes (ePRO) Market Analyzed
with Annual Revenue Figures in US$ Million for Years 2013
through 2020 (includes corresponding Graph/Chart) II-81

Table 23: World Historic Review for Electronic Patient
Reported Outcomes (ePRO) Market Analyzed with Annual Revenue
Figures in US$ Million for Years 2010 through 2012 (includes
corresponding Graph/Chart) II-81

Table 24: World Recent Past, Current and Future Analysis for
Randomization and Trial Supply Management (RTSM) Market
Analyzed with Annual Revenue Figures in US$ Million for Years
2013 through 2020 (includes corresponding Graph/Chart) II-82

Table 25: World Historic Review for Randomization and Trial
Supply Management (RTSM) Market Analyzed with Annual Revenue
Figures in US$ Million for Years 2010 through 2012 (includes
corresponding Graph/Chart) II-82


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Current and Future Analysis III-1
Product/Service Introductions III-1
Strategic Corporate Developments III-7
Select Key Players III-11
B.Market Analytics III-24
Table 26: The US Recent Past, Current and Future Analysis for
E-Clinical Trial Technologies Market Analyzed with Annual
Revenue Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-24

Table 27: The US Historic Review for E-Clinical Trial
Technologies Market Analyzed with Annual Revenue Figures in
US$ Million for Years 2010 through 2012 (includes
corresponding Graph/Chart) III-25

2. CANADA III-26
A.Market Analysis III-26
Current and Future Analysis III-26
Strategic Corporate Development III-26
B.Market Analytics III-26
Table 28: Canadian Recent Past, Current and Future Analysis
for E-Clinical Trial Technologies Market Analyzed with
Annual Revenue Figures in US$ Million for Years 2013 through
2020 (includes corresponding Graph/Chart) III-26

Table 29: Canadian Historic Review for E-Clinical Trial
Technologies Market Analyzed with Annual Revenue Figures in
US$ Million for Years 2010 through 2012 (includes
corresponding Graph/Chart) III-27

3. EUROPE III-28
A.Market Analysis III-28
Current and Future Analysis III-28
Product/Service Introductions III-28
Strategic Corporate Developments III-29
Select Key Players III-30
B.Market Analytics III-32
Table 30: European Recent Past, Current and Future Analysis
for E-Clinical Trial Technologies Market Analyzed with
Annual Revenue Figures in US$ Million for Years 2013 through
2020 (includes corresponding Graph/Chart) III-32

Table 31: European Historic Review for E-Clinical Trial
Technologies Market Analyzed with Annual Revenue Figures in
US$ Million for Years 2010 through 2012 (includes
corresponding Graph/Chart) III-33

4. ASIA-PACIFIC III-34
A.Market Analysis III-34
Current and Future Analysis III-34
Overview of Key Markets III-34
Japan III-34
China III-34
China- A Potential, Yet Challenging Market III-34
Chinese Pharma Companies Still Aloof to EDC Adoption III-34
Price Corrections - A Bare Necessity for Vendors to Succeed III-35
Smaller Vendors Possess Better Prospects in Immediate Future III-35
Australia III-35
Australia Makes Strong Pitch for Clinical Trials III-35
Major Challenges Facing Australian Clinical Trials Market III-36
Strategic Corporate Developments III-36
B.Market Analytics III-38
Table 32: Asia-Pacific (including Japan) Recent Past,
Current and Future Analysis for E-Clinical Trial Technologies
Market Analyzed with Annual Revenue Figures in US$ Million
for Years 2013 through 2020 (includes corresponding
Graph/Chart) III-38

Table 33: Asia-Pacific (including Japan) Historic Review for
E-Clinical Trial Technologies Market Analyzed with Annual
Revenue Figures in US$ Million for Years 2010 through 2012
(includes corresponding Graph/Chart) III-39

5. REST OF WORLD III-40
A.Market Analysis III-40
Current and Future Analysis III-40
The Middle East - Brimming with Potential for Clinical Trials III-40
Table 34: The Middle East Clinical Trial Market (2014):
Percentage Breakdown of Registered Clinical Trials in
Israel, Turkey, Iran, Saudi Arabia, Lebanon, and Rest of
Middle East (includes corresponding Graph/Chart) III-40
B.Market Analytics III-41
Table 35: Rest of World Recent Past, Current and Future
Analysis for E-Clinical Trial Technologies Market Analyzed
with Annual Revenue Figures in US$ Million for Years 2013
through 2020 (includes corresponding Graph/Chart) III-41

Table 36: Rest of World Historic Review for E-Clinical Trial
Technologies Market Analyzed with Annual Revenue Figures in
US$ Million for Years 2010 through 2012 (includes
corresponding Graph/Chart) III-42


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 85 (including Divisions/Subsidiaries - 92)

The United States (58)
Canada (2)
Japan (1)
Europe (27)
- France (2)
- Germany (3)
- The United Kingdom (12)
- Italy (2)
- Rest of Europe (8)
Asia-Pacific (Excluding Japan) (4)

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