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EDC and ePRO Market Trends and Service Provider Performance

  • May 2013
  • -
  • Industry Standard Research
  • -
  • 155 pages

This report analyzes the current and future use of electronic data capture (EDC) and electronic patient reported outcomes (ePRO) technologies in clinical trials. ISR quantifies study volume and vendor preference, identifies operational improvements, develops implications and recommendations for sponsors and service providers, and discusses the movement towards “eClinical” services.

The report also provides extensive product profiles of 20 EDC and 14 ePRO products based on 710 unique end-user experiences.

Regions Analyzed:

64% North America
28% Europe
8% Asia-Latin America-Middle East/ India

Valuable for:

• Project Managers
• Outsourcing
• Clinical Operations
• Data Management
• CROs
• Technology Service Providers

What you will learn in this report:

For Sponsors and CROs:
• 710 Site-coordinators and Principal Investigators’ product experiences and preferences across 20 EDC and 14 ePRO platforms
• 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 34 major technology providers across core performance attributes
• Current and future adoption estimates for EDC and 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 investigative sites would recommend improving the trial process
• Benchmark your organization’s use of EDC and ePRO against broad industry averages

For Technology Provides:
• 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 success and optimize user experience

EDC Products Included:

• Acceliant/ Trianz
• Bioclinica/ Phoenix Data Systems
• Clinical Ink
• Clinipace (Tempo)
• Cmed (Timaeus)
• DataLabs/ Perceptive Informatics
• DATATRAK
• DSG
• Medidata (Rave)
• MedNet Solutions
• Medrio
• Merge
• Nextrials (Prism)
• Octagon (Fuse)
• OmniComm (TrialMaster)
• OpenClinica
• Oracle/ Phase Forward (InForm)
• Registrat-MAPI
• Target Health
• Xclinical (Marvin)

ePRO Products Included:

• Almac
• Biomedical Systems (Michelangelo)
• Bracket Global/ Arrowhead
• Clinipace (Tempo)
• CRF Health
• DSG (eDiaryLink)
• ERT/ invivodata
• Exco Intouch
• ICOPhone (ICON)
• Outcome
• Perceptive Informatics
• PHT
• Registrat-MAPI
• Symfo

Table Of Contents

EDC and ePRO Market Trends and Service Provider Performance
Table of Contents
Copyright and Usage Guidelines 5
Introduction 6
Methodology 7
Respondent Demographics and Qualifications 8
Major Sections 10
Executive Summary 11
EDC Market Adoption 21
Number of EDC systems currently using 21
EDC vs. paper CRF preference 22
Past two years: percent of trials using EDC by development phase 23
Next two years: percent of trials using EDC by development phase 24
Summary: percent of trials using EDC by development phase 25
EDC Operational Improvements 26
Most impactful EDC product attributes for trial success 26
Suggested improvements to EDC systems 27
Mindset of sites heading into an EDC trial 31
Solutions to reduce the time needed to conduct a trial 35
EDC systems that best integrates with IVR systems 37
EDC systems that best integrates with ePRO technologies 38
EDC Service Provider Performance 39
Familiarity level of leading EDC providers 39
Use/ experience level of leading EDC providers 40
Most preferred EDC software application 42
Rationale for why an EDC system is preferred 43
EDC vendor satisfaction 47
Human-machine interface (how intuitive the software is to operate) 47
The process for dealing with queries 49
Speed of the applications, how fast the pages load 51
Technical support from the vendor 53
Integration capabilities with other applications (ePRO, IVR) 55
Overall satisfaction with the EDC product 57
Acceliant/ Trianz profile 59
Bioclinica/ Phoenix Data Systems profile 60
Clinical Ink profile 61
Clinipace (Tempo) profile 62
Cmed (Timaeus) profile 63
DataLabs/ Perceptive Informatics profile 64
DATATRAK profile 65
DSG profile 66
Medidata (Rave) profile 67
MedNet Solutions profile 68
Medrio profile 69
Merge profile 70
Nextrials (Prism) profile 71
Octagon (Fuse) profile 72
OmniComm (TrialMaster) profile 73
OpenClinica profile 74
Oracle/ Phase Forward (InForm) profile 75
Registrat-MAPI profile 76
Target Health profile 77
Xclinical (Marvin) profile 78
ePRO Market Adoption 79
Number of ePRO systems currently using 79
ePRO vs. paper diary preference 80
Past two years: percent of trials using ePRO vs. paper diaries by development phase 81
Next two years: percent of trials using ePRO vs. paper diaries by development phase …… 82
Summary: percent of trials using ePRO vs. paper diaries by development phase 83
Past two years: percent of trials using a PRO component 84
Next two years: percent of trials using a PRO component 85
Summary: percent of trials using a PRO component 86
ePRO Operational Improvements 87
Most impactful ePRO product attributes for trial success 87
Suggested improvements to ePRO systems 88
Mindset of sites heading into an ePRO trial 91
Solutions to reduce the time needed to conduct a trial 94
ePRO systems that best integrates with IVR systems 96
ePRO systems that best integrates with EDC technologies 97
ePRO Service Provider Performance 98
Familiarity level of leading ePRO providers 98
Use/ experience level of leading ePRO providers 99
Most preferred ePRO software application 101
Rationale for why an ePRO system is preferred 102
ePRO vendor satisfaction 104
Human-machine interface (how intuitive the SW is to operate) for the ePRO device 104
Human-machine interface (how intuitive the SW is to operate) for the ePRO web reporting
tool 106
Patient/ subject satisfaction with the ePRO application 108
Durability of the products once the subject has the device 110
Logistic of getting the devices to your site 112
Logistic of returning the devices to the vendor 114
Technical support from the vendor 116
Integration capabilities with other applications (EDC, IVR) 118
Overall satisfaction with the ePRO product 120
Almac profile 122
Biomedical Systems (Michelangelo) profile 123
Bracket Global/ Arrowhead profile 124
Clinipace (Tempo) profile 125
CRF Health profile 126
DSG (eDiaryLink) profile 127
ERT/ invivodata profile 128
Exco Intouch profile 129
ICOPhone (ICON) profile 130
Outcome profile 131
Perceptive Informatics profile 132
PHT profile 133
Registrat-MAPI profile 134
Symfo profile 135
eClinical Environment 136
Familiarity with EDC as source data - FDA guidance 136
Interest in direct data capture devices 137
Experience with integrated eClinical systems 138
eClinical systems used 139
eClinical benefits to sites 140
Most beneficial eClinical features to improve site operations 145
Most used CROs in past 18 months 146
Most recommended CROs for eClinical technology 147
Best CRO for eClinical support 148
Respondent Demographics 149
Practice setting 149
Job role 149
Clinical trial responsibility 150
Clinical trial recent activity 150
Geography 151
Familiarity with EDC and ePRO 151
Personal number of clinical trials, past 12 months 152
Site number of clinical trials, past 12 months 152
Industry/ clinical trial experience 153
Therapeutic area responsibility 154
About Industry Standard Research 155




Companies Mentioned

Acceliant/ Trianz
Bioclinica/ Phoenix Data Systems
Clinical Ink
Clinipace (Tempo)
Cmed (Timaeus)
DataLabs/ Perceptive Informatics
DATATRAK
DSG
Medidata (Rave)
MedNet Solutions
Medrio
Merge
Nextrials (Prism)
Octagon (Fuse)
OmniComm (TrialMaster)
OpenClinica
Oracle/ Phase Forward (InForm)
Registrat-MAPI
Target Health
Xclinical (Marvin)
Almac
Biomedical Systems (Michelangelo)
Bracket Global/ Arrowhead
Clinipace (Tempo)
CRF Health
DSG (eDiaryLink)
ERT/ invivodata
Exco Intouch
ICOPhone (ICON)
Outcome
Perceptive Informatics
PHT
Registrat-MAPI
Symfo

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