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
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 & Biotech R&D 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 & 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 & 2018): Percentage
Share Breakdown of Number of Connections by Type of Network
Technology (includes corresponding Graph/Chart) II-22
Smartphones & 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 & 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 SynCapture™ 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 OS™ 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 iMedNet™ 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 OS™ 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 & 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 & 2020 (includes corresponding Graph/Chart) II-71

Table 13: World Recent Past, Current & 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 & 2020 (includes corresponding Graph/Chart) II-74

Table 16: World Recent Past, Current & 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 & 2020 (includes corresponding
Graph/Chart) II-77

Table 19: World Recent Past, Current & 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 & 2020
(includes corresponding Graph/Chart) II-80

Table 22: World Recent Past, Current & 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 & 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 & 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 & 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 & Future Analysis III-26
Strategic Corporate Development III-26
B.Market Analytics III-26
Table 28: Canadian Recent Past, Current & 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 & 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 & 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 & 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 & 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 & 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 & 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)