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EDC and ePRO Market Trends and Service Provider Performance - Product Image

EDC and ePRO Market Trends and Service Provider Performance

  • ID: 2739734
  • April 2013
  • 155 Pages
  • Industry Standard Research (ISR)

FEATURED COMPANIES

  • Acceliant/ Trianz
  • Clinipace (Tempo)
  • DSG (eDiaryLink)
  • MedNet Solutions
  • OmniComm (TrialMaster)
  • Registrat-MAPI
  • MORE

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.

FEATURED COMPANIES

  • Acceliant/ Trianz
  • Clinipace (Tempo)
  • DSG (eDiaryLink)
  • MedNet Solutions
  • OmniComm (TrialMaster)
  • Registrat-MAPI
  • MORE

Copyright and Usage Guidelines
Introduction
Methodology
Respondent Demographics and Qualifications
Major Sections
Executive Summary
EDC Market Adoption
Number of EDC systems currently using
EDC vs paper CRF preference
Past two years: percent of trials using EDC by development phase
Next two years: percent of trials using EDC by development phase
Summary: percent of trials using EDC by development phase
EDC Operational Improvements
Most impactful EDC product attributes for trial success
Suggested improvements to EDC systems
Mindset of sites heading into an EDC trial
Solutions to reduce the time needed to conduct a trial
EDC systems that best integrates with IVR systems
EDC systems that best integrates with ePRO technologies
EDC Service Provider Performance
Familiarity level of leading EDC providers
Use/ experience level of leading EDC providers
Most preferred EDC software application
Rationale for why an EDC system is preferred
EDC vendor satisfaction
Human-machine interface (how intuitive the software is to operate)
The process for dealing with queries
Speed of the applications, how fast the pages load
Technical support from the vendor
Integration capabilities with other applications (ePRO, IVR)
Overall satisfaction with the EDC product
Acceliant/ Trianz profile
Bioclinica/ Phoenix Data Systems profile
Clinical Ink profile
Clinipace (Tempo) profile
Cmed (Timaeus) profile
DataLabs/ Perceptive Informatics profile
DATATRAK profile
DSG profile
Medidata (Rave) profile
MedNet Solutions profile
Medrio profile
Merge profile
Nextrials (Prism) profile
Octagon (Fuse) profile
OmniComm (TrialMaster) profile
OpenClinica profile
Oracle/ Phase Forward (InForm) profile
Registrat-MAPI profile
Target Health profile
Xclinical (Marvin) profile
ePRO Market Adoption
Number of ePRO systems currently using
ePRO vs paper diary preference
Past two years: percent of trials using ePRO vs paper diaries by development phase
Next two years: percent of trials using ePRO vs paper diaries by development phase ……
Summary: percent of trials using ePRO vs paper diaries by development phase
Past two years: percent of trials using a PRO component
Next two years: percent of trials using a PRO component
Summary: percent of trials using a PRO component
ePRO Operational Improvements
Most impactful ePRO product attributes for trial success
Suggested improvements to ePRO systems
Mindset of sites heading into an ePRO trial
Solutions to reduce the time needed to conduct a trial
ePRO systems that best integrates with IVR systems
ePRO systems that best integrates with EDC technologies
ePRO Service Provider Performance
Familiarity level of leading ePRO providers
Use/ experience level of leading ePRO providers
Most preferred ePRO software application
Rationale for why an ePRO system is preferred
ePRO vendor satisfaction
Human-machine interface (how intuitive the SW is to operate) for the ePRO device
Human-machine interface (how intuitive the SW is to operate) for the ePRO web reporting
tool
Patient/ subject satisfaction with the ePRO application
Durability of the products once the subject has the device
Logistic of getting the devices to your site
Logistic of returning the devices to the vendor
Technical support from the vendor
Integration capabilities with other applications (EDC, IVR)
Overall satisfaction with the ePRO product
Almac profile
Biomedical Systems (Michelangelo) profile
Bracket Global/ Arrowhead profile
Clinipace (Tempo) profile
CRF Health profile
DSG (eDiaryLink) profile
ERT/ invivodata profile
Exco Intouch profile
ICOPhone (ICON) profile
Outcome profile
Perceptive Informatics profile
PHT profile
Registrat-MAPI profile
Symfo profile
eClinical Environment
Familiarity with EDC as source data – FDA guidance
Interest in direct data capture devices
Experience with integrated eClinical systems
eClinical systems used
eClinical benefits to sites
Most beneficial eClinical features to improve site operations
Most used CROs in past 18 months
Most recommended CROs for eClinical technology
Best CRO for eClinical support
Respondent Demographics
Practice setting
Job role
Clinical trial responsibility
Clinical trial recent activity
Geography
Familiarity with EDC and ePRO
Personal number of clinical trials, past 12 months
Site number of clinical trials, past 12 months
Industry/ clinical trial experience
Therapeutic area responsibility
About Industry Standard Research

FEATURED COMPANIES

  • Acceliant/ Trianz
  • Clinipace (Tempo)
  • DSG (eDiaryLink)
  • MedNet Solutions
  • OmniComm (TrialMaster)
  • Registrat-MAPI
  • MORE

This report provides the pharmaceutical industry and its service providers with novel insights into the current and future use of these technologies and enables better technology provider selection.

“From a classical market development point of view, EDC technology has finally ‘crossed the chasm’ and has become the de facto data collection mechanism for clinical trials,” Andrew Schafer, President of ISR explained. “While ePRO does not start from the same vantage point – not all studies need a patient-reported outcome component – we do see the ePRO market maturing and several products beginning to emerge as market leaders.”

This study surveyed 101 site-coordinators and principal investigators with responsibility for data collection at their sites. The data captured represent 710 on-the-ground service experiences across 20 EDC and 14 ePRO products.

“With this data, sponsors can make more informed outsourcing decisions, improve relationships with sites by utilizing technology platforms they prefer, and build efficiencies into study designs,” Schafer explained. “For service providers, this ‘Voice-of-the-Customer’ research offers unique product satisfaction data from end-users on their product and their competitors.”

In addition to end-user satisfaction data, the report also provides service providers with important insights into current and future EDC and ePRO market trends, including: adoption, usage, preference, study penetration by Phase, and the new ‘eClinical’ service many large CROs are beginning to offer that is sure to impact the competitive landscape.

- 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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