EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015)
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The report analyzes the electronic data capture (EDC) and electronic clinical outcome assessments (ECOA/EPRO) market dynamics based on feedback from over 150 industry professionals, including performance evaluations of 22 EDC and 22 ECOA/EPRO service providers across various attributes. It highlights current usage trends, outsourcing preferences, and emphasizes the growing role of these technologies in ensuring high-quality data for clinical trials. Additionally, the document provides benchmarks for sponsors and clinical research organizations (CROs) to inform their technology partnerships and optimize trial processes.
EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015)
- 1. 20152015 EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015) Info@ISRreports.com ©2015 Industry Standard Research www.ISRreports.com PREVIEW
- 2. www.ISRreports.com ©2015 | Preview of: EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015) 2 act with confidence 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 136Pages 121Charts 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
- 3. www.ISRreports.com ©2015 | Preview of: EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015) 3 act with confidence 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:
- 4. www.ISRreports.com ©2015 | Preview of: EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015) 4 act with confidence Table of Contents For full table of contents and additional sample pages, download the full preview from: www.isrreports.com/?p=5699
- 5. www.ISRreports.com ©2015 | Preview of: EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015) 5 act with confidence act with confidence Introduction www.ISRreports.com ©2015 | EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015) 7 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� www.ISRreports.com ©2015| EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015) 7 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 %ofServiceEncounters Provider Concentration EDC ePRO Number of providers Provider Concentration (2015) Sample Page
- 6. www.ISRreports.com ©2015 | Preview of: EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015) 6 act with confidence act with confidence Executive Summary www.ISRreports.com ©2015 | EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015) 20 Service Provider Performance by Category ISR 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 Health ClinPhone IVR ePRO (PAREXEL) Biomedical Systems (Michelangelo) Usability ERT/invivodata (diarypro/sitepro) OutcomeLogix (Oracle) Almac ClinPhone 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 B Company G Company E System/Device Integration Company B Company E Company A Company G Company F System Flexibility and Support Company A Company E Company G Company I Validation and Patient Compliance Company A Company B Company H Company E Service Provider Performance by Category ISR 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.
- 7. www.ISRreports.com ©2015 | Preview of: EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015) 7 act with confidence Sample Page act with confidence EDC Provider Selection Criteria www.ISRreports.com ©2015 | EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015) 42 Contract Directly vs� Going through CRO for EDC Components Roughly 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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