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

20152015

EDC and eCOA/ePRO Market Dynamics

and Service Provider Performance (2015)

[email protected]

©2015 Industry Standard Research www.ISRreports.com

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Report Overview

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 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 22 EDC and 22 eCOA/ePRO systems based on 651 EDC and 432 ePRO service provider encounters. Each provider’s performance is evaluated and benchmarked based on the performance of these providers against expectations across 18-21 attributes.

166Respondents

136 Pages

121 Charts and Graphs

Q2, 2015

Publication Date

1. Executive Summary: In this section, ISR summarizes the key findings found throughout the report. The majority of these data are examined in more detail in the subsequent sections.

2. EDC Market Environment: Examines how respondents’ companies are utilizing EDC systems, how these systems are impacting clinical trial activity, and how they could see these systems improved moving forward.

3. EDC Provider Selection Criteria: Outlines the criteria by which sponsors and CROs select service providers for EDC-related services as well as respondents’ preferences for specific EDC platforms.

4. EDC Service Provider Performance: Evaluates the performance of 22 different EDC service providers across 18 different performance attributes.

5. eCOA/ePRO Market Environment: Examines how respondents’ companies are utilizing eCOA/ePRO systems, how these systems are impacting clinical trial activity, and how they could see these systems improved moving forward.

6. eCOA/ePRO Provider Selection Criteria: Outlines the criteria by which sponsors and CROs select service providers for eCOA/ePRO-related services as well as respondents’ preferences for specific eCOA/ePRO technologies.

7. eCOA/ePRO Service Provider Performance: Evaluates the performance of 22 different eCOA/ePRO service providers across 21 different performance attributes.

8. Demographics: Provides the reader with an understanding of the demographics for the 166 respondents whose opinions are gathered and evaluated in this report.

• Project Managers

• Outsourcing

• Clinical Operations

• Data Management

• CROs

• Technology Service Providers

Major Sections:

Regions Analyzed: Valuable for:

56% North America

35% Europe

10% Asia, Latin America, Middle East/India

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Report Metrics

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

• Acceliant/Trianz • BioClinica/Express EDC • CiSIV • Clinical Ink • Clinipace (Tempo) • Clinovo/ClinCapture • Cmed (Timaeus) • DataLabs

• DATATRAK • DSG • Forte Research Systems/Overture

EDC • Medidata (Rave) • MedNet Solutions • Medrio • Merge eClinical OS

• Nextrials (Prism) • Octagon (Fuse) • OmniComm (TrialMaster) • OpenClinica • Oracle/Phase Forward (InForm) • Target Health • Xclinical (Marvin)

• Almac • AMC Health • Biomedical Systems

(Michelangelo) • Bracket Global/Arrowhead • Clinipace (Tempo) • ClinPhone IVR ePRO (by

PAREXEL) • CRF Health (TrialMax) • DATATRAK ONE UX Patient Data

Capture

• DSG (eDiaryLink) • ePharmaSolutions • ERT/invivodata (diarypro/ sitepro) • Exco Intouch • ICOPhone (by ICON Clinical) • Inspire • Medidata Patient Cloud • mProve Health (formerly

Omniscience) • OutcomeLogix (by Oracle) • PatientsLikeMe

• PharmaNet/i3 IRT (by inVentiv Health Clinical)

• PHT • Symfo • Y-Prime

eCOA/ePRO Products Included:

EDC Products Included:

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Table of ContentsFor full table of contents and additional sample pages, download the full preview from: www.isrreports.com/?p=5699

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Introduction

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Introduction

Electronic data capture (EDC), electronic clinical outcome assessments (eCOA), and electronic patient reported outcomes (ePRO) systems have become essential and effective tools to appropriately capture, review, and even present the data accumulated throughout the course of a clinical trial� While paper CRFs are still preferred by some respondents, that figure is dwindling� EDC has become the standard tool for its job in clinical trials across the board� Similarly, eCOA and ePRO systems ensure that the data collected during a clinical trial are of the highest quality� Ever more, sponsors and CROs alike are turning to these systems to ensure the highest quality data and to save money by reducing trial delays associated with data capture difficulties�

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 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 22 EDC and 22 eCOA/ePRO systems based on 651 EDC and 432 ePRO service provider encounters� Each provider’s performance is benchmarked based on the performance of these providers against expectations across 18-21 attributes� While the specifics of these ratings are contained within this report, ISR wanted to include a comparison of a piece of this year’s data to historical data captured in a previous version of this report� In 2013, ISR found that 2 providers accounted for over 50% of the EDC service encounters of respondents� Similarly, 4 companies accounted for over 50% of eCOA/ePRO service encounters� Interestingly, as the market for these services grows, so too does the space for additional successful providers of these services� In this year’s report, 5 EDC providers and 7 ePRO providers make up over 50% of service encounters�

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Introduction Electronic data capture (EDC), electronic clinical outcome assessments (eCOA), and electronic patient reported outcomes (ePRO) systems have become essential and effective tools to appropriately capture, review and even present the data accumulated throughout the course of a clinical trial. While paper CRFs are still preferred by some respondents, that figure is dwindling. EDC has become the standard tool for its job in clinical trials across the board. Similarly, eCOA and ePRO systems ensure that the data collected during a clinical trial are of the highest quality. Ever more, sponsors and CROs alike are turning to these systems to ensure the highest quality data, and to save money by reducing trial delays associated to difficulties related with data capture. 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 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 22 EDC and 22 eCOA/ePRO systems based on 651 EDC and 432 ePRO service provider encounters. Each provider’s performance is benchmarked based on the performance of these providers against expectations across 18/21 attributes. While the specifics of these ratings are contained within this report, ISR wanted to include a comparison of a piece of this year’s data to historical data captured in a previous version of this report. In 2013, ISR found that 2 providers accounted for over 50% of the EDC service encounters of respondents. Similarly, 4 companies accounted for over 50% of eCOA/ePRO service encounters. Interestingly, as the market for these services grows, so too does the space for additional successful providers of these services. In this year’s report, 5 EDC providers and 7 ePRO providers make up over 50% of service encounters.

0%

25%

50%

75%

100%

1   2   3   4   5   6   7   8   9   10  

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Provider Concentration

EDC ePRO

Number of providers

Provider Concentration (2015)

Sample Page

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Executive Summary

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Service Provider Performance by CategoryISR asked respondents to rate each eCOA/ePRO provider they have recently used across 21 different dimensions of performance� ISR’s methodology for doing so asks each user to rate the service’s performance vs� the user’s expectations for each dimension� Scores are assigned to ratings as follows:

• Greatly exceeded my expectations; +3• Somewhat exceeded my expectations: +1• Met my expectations: 0• Somewhat fell short of my expectations: -1• Greatly fell short of my expectations: -3

ISR then organized these attributes into categories and produced an average score for each category� The chart below shows the first, second, and third highest rated companies by category as well as those companies that were close contenders�

ERT/invivodata (diarypro/sitepro) and ClinPhone IVR ePRO (by PAREXEL) appear in the top 4 in 5 of the 6 performance categories� Outcome Logix (by Oracle) despite not being heavily used by respondents ranked in the top 2 in 4 of six categories� This suggests that in addition to OutcomeLogix exceeding performance expectations by users, they may have opportunity for growth� ERT/invivodata and ClinPhone both have high performance scores but are also used more often than OutcomeLogix� For sponsors, it may be worth exploring the services offered by OutcomeLogix, particularly since one of the categories in which they lead is Reasonableness of Cost.

Attributes Rated Highest Second Highest Third Highest Close Contenders

Overall satisfaction

ERT/invivodata (diarypro/sitepro)

Medidata Patient Cloud

CRF Health (TrialMax)

Inspire

ClinPhone IVR ePRO (PAREXEL)

Almac

Reasonableness of Cost

OutcomeLogix (Oracle)

AMC HealthClinPhone IVR ePRO

(PAREXEL)Biomedical Systems

(Michelangelo)

UsabilityERT/invivodata

(diarypro/sitepro)OutcomeLogix

(Oracle)

AlmacClinPhone IVR ePRO

(PAREXEL)

System/Device Integration

OutcomeLogix (Oracle)

ClinPhone IVR ePRO (PAREXEL)

ERT/invivodata (diarypro/sitepro)

AMC Health

CRF Health (TrialMax)

System Flexibility and Support

ERT/invivodata (diarypro/sitepro)

ClinPhone IVR ePRO (PAREXEL)

Almac PHT

Validation and Patient Compliance

ERT/invivodata (diarypro/sitepro)

OutcomeLogix (Oracle)

Biomedical Systems (Michelangelo)

ClinPhone IVR ePRO (PAREXEL)

Sample Page

Attributes Rated Highest Second Highest Third Highest Close Contenders

Overall satisfaction

Company A Company C

Company F

Company J

Company E

Company G

Reasonableness of Cost

Company B Company D Company E Company H

Usability Company A Company BCompany G

Company E

System/Device Integration

Company B Company E Company ACompany G

Company F

System Flexibility and Support

Company A Company ECompany G

Company I

Validation and Patient Compliance

Company A Company B Company H Company E

Service Provider Performance by CategoryISR asked respondents to rate each eCOA/ePRO provider they have recently used across 21 different dimensions of performance. ISR’s methodology for doing so asks each user to rate the service’s performance vs. the user’s expectations for each dimension. Scores are assigned to ratings as follows:

• Greatly exceeded my expectations: +3• Somewhat exceeded my expectations: +1• Met my expectations: 0• Somewhat fell short of my expectations: -1• Greatly fell short of my expectations: -3

ISR then organized these attributes into categories and produced an average score for each category. The chart below shows the first, second, and third highest rated companies by category as well as those companies that were close contenders.

Company A and Company E appear in the top 4 in 5 of the 6 performance categories. Company B despite not being heavily used by respondents ranked in the top 2 in 4 of six categories. This suggests that in addition to Company B exceeding performance expectations by users, they may have opportunity for growth. Company A and Company E both have high performance scores but are also used more often than Company B. For sponsors, it may be worth exploring the services offered by Company B, particularly since one of the categories in which they lead is Reasonableness of Cost.

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EDC Provider Selection Criteria

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Contract Directly vs� Going through CRO for EDC ComponentsRoughly half the time, sponsors contract directly with an EDC provider as opposed to going through the CRO� Moving forward, this figure is expected to increase by roughly 10 percentage points� Similarly, moving forward, CROs expect a decline in how often the sponsor almost always contracts through our organization (being the CRO)� Currently 52% of respondents from CROs say this, but in three years’ time, only 39% of CRO respondents expect this to be the case�

“Currently, when your organization is using a CRO for a clinical study that has an EDC component, what percent of the time do you contract directly with an EDC provider as opposed to going through the CRO?” (Base=50; sponsors only)

“Thinking three years into the future, when your organization is using a CRO for a clinical study that has an EDC component, what percent of the time will you contract directly with an EDC provider as opposed to going through the CRO?” (Base=48; sponsors only)

43%

52%

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Sample Page

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