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eCOA (electronic clinical outcome assessment) and ePRO (electronic patient-reported outcome) have been gaining traction as services/technologies used in clinical development. The data in this report indicate some of the largest anticipated growth in this area that ISR has seen over the past ten years. The world is shifting toward patient feedback, real-time data collection, conditional approvals, personalized medicine, BYOD (bring your own device), mHealth data collection and analysis – all of these changes bode well for eCOA/ePRO expansion. This report examines the industry perception of the eCOA/ePRO market based on the responses of 117 industry professionals experienced with these systems. ISR has asked respondents 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 17 eCOA/ePRO systems based on more than 400 service provider encounters. Each provider’s performance is benchmarked based on the performance of these providers against expectations across 23 attributes.
Sponsors and CROs:
- 400+ service provider encounters with 17 eCOA/ePRO systems.
- Bird’s eye view of the eCOA/ePRO market and the decline of paper solutions, criteria used for provider selection, and service provider performance.
- Which providers may fit your needs best – a range of attributes or focused needs, smaller provider versus larger provider, degree of device integration-ready, etc.
- 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, especially device integration.
- Understand your company’s and the competition’s position in the marketplace in terms of familiarity and use – this market remains highly fragmented with some providers having notably more market presence than others.
- Executive Summary
- Market Environment
- Provider Selection Criteria
- Service Provider Performance
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Pricing & Ordering
Table of Contents
eCOA/ePRO Market Landscape
Continued Growth in the Use of eCOA/ePRO Systems
eCOA/ePRO Software Use
Overall Provider Satisfaction
Service Provider Performance by Category
Suggestions for Improvement for eCOA/ePRO Systems
eCOA/ePRO Market Environment
Primary Section Takeaways
Number of eCOA/ePRO Systems Used (Current and Projected)
Preference for eCOA/ePRO vs. Paper Diaries
Use of Electronic Solutions vs. Paper (Past and Projected)
Preference for Device-based Interface
Percent of Trials Using eCOA/ePRO Component (Past and Projected)
Use of Direct Data Capture Sensors/Wearables for Patient Measurements (Past and Projected)
Source of Clinical Reported Outcomes (Past and Projected)
Source of Clinical Outcome Assessments (Past and Projected)
How to Improve Functionality of eCOA/ePRO Software Systems
Impact of eCOA/ePRO Product Attributes on Trial Success
eCOA/ePRO Provider Selection Criteria
Primary Section Takeaways
Most Important Attributes for eCOA/ePRO Provider Selection
Influencing Sponsor In-house eCOA/ePRO Provider Selection
Influencing CRO eCOA/ePRO Provider Selection
Influence of Sponsor Organizations on eCOA/ePRO Provider Selection When Using a CRO for Studies
Contract Directly vs. Going through CRO for eCOA/ePRO Components
eCOA/ePRO Service Provider Performance
Primary Section Takeaways
eCOA/ePRO Service Provider Level of Familiarity
Use/Experience Level with Leading eCOA/ePRO Providers
Satisfaction with eCOA/ePRO Providers by Performance Attribute
Biomedical Systems (an ERT company)
CRF Health (TrialMax)
DATATRAK ONE UX Patient Data Capture
Exco Intouch (an ERT company)
Medidata Patient Cloud
mProve Health (a Bracket company)
PAREXEL Informatics (Clinphone IVR ePRO)
PHT (an ERT company)
eCOA/ePRO Provider Preference for Development- and Late-Stage Trials
Type of Office/Practice
Most Recent Clinical Trial
Involvement in Clinical Trials (Past 12 Months)
Role of Organization in Clinical Trial
Roles and Responsibilities
CRO Experience (Past 18 Months)
CROs Likely to Recommend Based on eClinical Capabilities
Therapeutic Areas of Responsibility