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EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015)

  • May 2015
  • -
  • Industry Standard Research
  • -
  • 136 pages

This report examines the industry perception of the EDC and eCOA/ePRO markets based on the responses of over 150 industry professionals experienced with these systems. ISR has asked CROs and sponsors how their respective companies handle the decisions associated with outsourcing these systems as well as how they would prefer the outsourcing be handled. Additionally, ISR has benchmarked 22 EDC and 22 eCOA/ePRO systems based on 651 EDC and 432 ePRO service provider encounters from investigative sites, CROs and sponsors. Each provider’s performance is evaluated and benchmarked based on the performance of these providers against expectations across 18-21 attributes.

What you will learn in this report:

For Sponsors and CROs:
- 651 EDC product experiences and 432 ePRO product experiences with 22 EDC and 22 eCOA/ePRO products
- Past and future penetration of EDC and ePRO technologies (by phase of development)
- Which technology providers have the best integration capabilities with other technologies

For Technology Providers:
- Detailed performance profiles, product satisfaction, and end-user preference for 44 major technology providers across core performance attributes
- Current and future adoption estimates for EDC and eCOA/ePRO technologies

How you can use this report:

For Sponsors and CROs:
- Select or uncover a new technology partner that enhances your relationships with sites by understanding the needs, wants, and preferences of clinical sites
- Learn how sites, CROs, and sponsors would recommend improving the trial process
- Benchmark your organization’s use of EDC and eCOA/ePRO against broad industry averages

For Technology Providers:
- Benchmark your performance against your competition
- Anticipate how changes in trial volume and adoption/penetration will affect your future business opportunities
- Identify operational improvements and product characteristics that impact trial

Table Of Contents

EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015)
Table of Contents

Copyright and Usage Guidelines..6
Introduction ...7
Methodology ..8
Respondent Demographics and Qualifications ..9
Company Type ..9
Geography ..9
Familiarity with Technology ..10
Major Sections .11
Executive Summary ...12
EDC Market Landscape ..13
Growth in the Use of EDC Systems .14
Service Provider Performance Categories .15
Overall Satisfaction Summary ...16
EDC Software Use ...17
Improvements for EDC Systems ..18
eCOA/ePRO Market Landscape ...19
Growth in the Use of eCOA/ePRO Systems ..19
Service Provider Performance by Category ..20
Overall Satisfaction Summary ...21
eCOA/ePRO Software Use 22
Improvements for eCOA/ePRO Systems ...23
EDC Market Environment 24
Number of EDC Systems Used (Current and Projected) 25
Preference for EDC vs. Paper CRF ..26
Use of Data Collection Tools by Phase (Current and Projected) .27
Phase I ...27
Phase II ..28
Phase III .28
Phase IV .29
Use of Direct Data Capture Sensors and/or Wearables .30
How to Improve Functionality of EDC Software Systems ..31
Solutions to Reduce the Time Needed to Conduct a Trial 33
Impact of EDC Product Attributes on Trial Success 34
EDC Provider Selection Criteria .35
Most Important Attributes for EDC Provider Selection ...36
Development Stage 37
Phase IV, Post Marketing ...38
Departmental Influence on EDC Provider Selection ...39
Influence of Other Entities on EDC Provider Selection ..40
Influence of Sponsor Organizations on EDC Provider Selection when Using a CRO for
Studies ...41
Contract Directly vs. Going through CRO for EDC Components ...42
EDC Service Provider Performance ..44
EDC Service Provider Awareness 45
EDC Service Provider Level of Familiarity ..47
Use/Experience Level with Leading EDC Providers 48
Satisfaction with EDC Providers by Attribute 49
Acceliant/Trianz ..49
BioClinica/ Express EDC 50
CiSIV ...51
Clinical Ink ... 52
Clinipace (Tempo) ...53
Clinovo/ClinCapture ..54
Cmed (Timaeus) ..55
DataLabs .. 56
DATATRAK 57
DSG 58
Forte Research Systems/Overture EDC .59
Medidata (Rave) ...60
MedNet Solutions 61
Medrio ...62
Merge eClinical OS .63
Nextrials (Prism) ..64
Octagon (Fuse) 65
OmniComm (TrialMaster) .66
OpenClinica ..67
Oracle/Phase Forward (InForm) ..68
Target Health ...69
Xclinical (Marvin) .70
EDC Provider Preference ...71
Development Stage Trials .72
Late-Stage Trials ..73
eCOA/ePRO Market Environment .74
Number of eCOA/ePRO Systems Used (Current and Projected) .75
Preference for eCOA/ePRO vs. Paper Diaries ...76
Use of Electronic Solutions vs. Paper (Past and Projected) ...77
Preference for Device-based Interface ..78
Percent of Trials Using eCOA/ePRO Component (Past and Projected) .79
Use of Direct Data Capture Sensors/Wearables for Patient Measurements (Past and Projected)
.80
Source of Clinical Report Outcomes ..81
Source of Clinical Outcome Assessments (Past and Projected) ..82
How to Improve Functionality of eCOA/ePRO Software Systems ..83
Impact of eCOA/ePRO Product Attributes on Trial Success .85
eCOA/ePRO Provider Selection Criteria ..86
Most Important Attributes for eCOA/ePRO Provider Selection 87
Development Stage 88
Late Stage .89
Influencing Sponsor In-house eCOA/ePRO Provider Selection ...90
Influencing CRO eCOA/ePRO Provider Selection ...91
Influence of Sponsor Organizations on eCOA/ePRO Provider Selection when Using a
CRO for Studies ...92
Contract Directly vs. Going through CRO for eCOA/ePRO Components .93
eCOA/ePRO Service Provider Performance ..94
eCOA/ePRO Service Provider Awareness ..95
eCOA/ePRO Service Provider Level of Familiarity ...96
Use/Experience Level with Leading eCOA/ePRO Providers .97
Satisfaction with eCOA/ePRO Providers by Attribute .98
Almac ...98
AMC Health ..99
Biomedical Systems (Michelangelo) .100
Bracket Global/Arrowhead 101
Clinipace (Tempo) 102
ClinPhone IVR ePRO (by PAREXEL) ...103
CRF Health (TrialMax) .104
DATATRAK ONE UX Patient Data Capture ..105
DSG (eDiaryLink) ...106
ePharmaSolutions ...107
ERT/ invivodata (diarypro/ sitepro) ...108
Exco Intouch ..109
ICOPhone (by ICON Clinical) .110
Inspire ...111
Medidata Patient Cloud ...112
mProve Health (formerly Omniscience) ...113
OutcomeLogix (by Oracle) ..114
PatientsLikeMe ...115
PharmaNet/i3 IRT (by inVentiv Health Clinical) ...116
PHT ...117
Symfo ...118
Y-Prime 119
eCOA/ePRO Provider Preference for Development-Stage Trials ..120
eCOA/ePRO Provider Preference for Late-Stage Trials ...122
Demographics .123
Type of Organization ...124
CRO of Respondents 125
Decision-making Responsibility 126
Type of Office/Practice 127
Most Recent Clinical Trial 128
Involvement in Clinical Trials (Past 12 Months) ...128
Role of Organization in Clinical Trial 129
Roles and Responsibilities ...130
Office Location ..131
EDC/ePRO Familiarity ..132
CRO experience (Past 18 Months) .133
CROs Likely to Recommend Based on eClinical Capabilities .134
Therapeutic Areas of Responsibility ..135
About Industry Standard Research .136

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