eTMF Market and Service Provider Dynamics

  • ID: 4226996
  • Report
  • Region: Global
  • 110 Pages
  • Industry Standard Research (ISR)
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The capital market is expecting big things from cloud-based applications servicing the health care and pharmaceutical markets. More and more systems, processes, files, storage, and approvals are moving towards cloud-based applications and trial master files are no exception. For this report, it was gauged how the adoption of eTMF systems is progressing and how it will continue to progress (or not) over the next few years. Data was collected from actual eTMF users at sponsor organizations and CROs. Their perspectives enable the report to provide a “hands-on” level of data analysis and evaluations of eTMF systems.

What You Will Learn:

  • eTMF vendor familiarity, leadership perception, and use
  • Market dynamics such as preferred provider agreement penetration
  • Decision-making units and processes within sponsor organizations and CROs
  • Top selection attributes/criteria used when selecting an eTMF provider
  • Top performance attributes/criteria used when evaluating an eTMF provider
  • Performance evaluations of the leading eTMF software providers

How You Can Use This Report:

Sponsors and CROs

  • Understand actual user experience and satisfaction with leading eTMF software providers
  • Better inform your eTMF buying and vendor selection process
  • Discover new eTMF providers to evaluate
  • Negotiate contracts from a data-based position of strength

For eTMF vendors

  • Understand the top selection attributes/criteria used when sponsors and CROs are selecting an eTMF provider and the top performance attributes/criteria used when they are evaluating an eTMF provider
  • Learn where your company sits in the competitive landscape and, therefore, where to focus sales and marketing efforts
  • Prepare better proposals and bid defenses based on understand the strengths and weaknesses of your competitors
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1. Introduction 

2. Methodology

3. Demographics And Qualifications

  • Role and responsibility
  • eClinical use and types
  • Types of eTMF(s) used
  • Company size
  • Number of performance ratings per company
  • 6 Major Sections

4. eTMF Preferences And Practices 

  • Primary Section Takeaways
  • Preference: eTMF vs paper
  • Percentage of TMF data managed in an eTMF
  • Current and future TMF data storage solutions
  • Primary solutions for document management

5. Preferred provider agreements  

  • Information exchange methods
  • Remote access to eTMF by auditors/inspector
  • Areas of innovation
  • Interest in new eTMF features
  • eTMF Perceptions And Interactions
  • Primary Section Takeaways
  • Familiarity with providers
  • Leaders in the field
  • Provider usage

6. eTMF Selection Drivers

  • Primary Section Takeaways
  • Most important selection attributes
  • Most important satisfaction attribute
  • Decision-making responsibilities and influence over eTMF selection
    • At Sponsor Organizations
    • At CRO Organizations

7. eTMF Provider Performance And Loyalty 

  • Primary Section Takeaways
  • Overall ease of use
  • Data security
  • Integration with other systems
  • Auditability
  • Customer Loyalty

8. Service Provider Drill-Downs 

  • Arivis (Clireo)
  • Biovia (QUMAS)
  • CareLex
  • Covance
  • Database Integrations
  • EMC
  • Ennov
  • Forte Research
  • Freyr
  • MasterControl
  • Mayo Clinic
  • Montrium
  • NCGS
  • NextDocs
  • Oracle
  • Paragon Solutions
  • PharmaVigilant I-Vault
  • Phlexglobal
  • Safe-BioPharma
  • SterlingBio
  • SureClinical
  • TransPerfect Trial Interactive
  • Veeva Vault
  • Wingspan Technology
  • WIRB-Copernicus / ePharmaSolutions

9. Study Data 

  • eTMF software vendor familiarity and leadership
    1. Software vendor familiarity
    2. eTMF provider leadership
  • eTMF systems
    • Percentage of TMF data managed in eTMF
    • Future percentage of TMF data managed in eTMF
    • Where TMF data are currently stored
    • Where TMF data will be stored in three years
    • Current solutions for document management
    • Future solutions for document management
  • Vendor agreements
    • Preferred provider agreements with eTMF vendors
    • Current number of preferred provider agreements
    • Future preferred provider agreements  with eTMF vendors
  • eTMF information exchange
    • Information exchange systems among organizations
    • Providing auditors with remote access to eTMF files (current)
    • Providing auditors with remote access to eTMF files (future)
    • Investigative sites with data upload capability to eTMF (current)
    • Future investigative sites with data upload capability to eTMF (future)
    • Current and future eTMF use for trial process improvement
  • Vendor selection drivers
    • Attribute importance in eTMF selection
    • Most important attribute in eTMF selection
    • Attribute importance in eTMF satisfaction
    • Most important attribute in eTMF satisfaction
    • eTMF vs paper TMF preference eTMF decision-making
  • eTMF Decision-Making
    • Sponsor influence over CRO eTMF selection
    • CRO perception of sponsor influence on eTMF selection
    • Sponsor departmental decision-making influence vs CRO influence
    • CRO departmental decision-making influence vs sponsor influence
    • eTMF software provider usage
  • Innovation
    • eTMF improvement and added functionality
    • Interest in potential additions to eTMF

10. Respondent Profile

  • eTMF selection responsibility
  • Age
  • Years of industry experience
  • Drug development involvement by phase
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