eTMF Market and Service Provider Dynamics (2nd edition)

Description

More and more systems, processes, files, storage, and approvals are moving towards cloud-based applications and trial master files are no exception. The capital market is expecting big things from cloud-based applications servicing the healthcare and pharmaceutical markets.
That said, not many providers are on respondents’ radars. The eTMF landscape is dominated by a few providers across measured vendor dimensions. A lot needs to be done to build awareness of the providers in this space. The potential is there, given a few lesser known providers did manage to crack the top ten rankings. It will be interesting to see if the eTMF market either diversifies or stays as is as the industry matures.
For sponsor organizations, CROs, and eTMF providers, this report is designed to provide your organization with information necessary to make smart decisions going forward.

Preview cover for 2019 eTMF Market and Service Provider Dynamics

Study 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

eTMF Providers

  • 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 understanding the strengths and weaknesses of your competitors
  • eTMF Preferences and Practices
  • eTMF Selection Drivers
  • eTMF Perceptions and Interactions
  • eTMF Software Provider Performance and Loyalty
  • Study Data

ISR understands that you’re looking for confidence in your market research. With ISR, you’ll consistently receive

  • Focused Domain Expertise — We’ve operated in pharmaceuticals for over 15 years and because it’s our sole focus, our domain expertise brings value to the work that “generalist” researchers can’t deliver.
  • Genuine Research Expertise — Our market research experience has developed over 20 years in many dynamic industries.  We capture appropriate sample sizes, given the research objectives, and we use appropriately sophisticated statistics to uncover everything that’s real and to give you confidence in your decisions. Read our Six Questions to Ask About Your Market Research to learn more about why our industry expertise sets us apart.
  • Transparency — If you’re like many, you’ve been disappointed more than once by research providers who fail to live up to their promises, providing you with their “professional judgment” in place of sound data; and suspect contacts instead of real decision-makers. We deliver the beliefs, attitudes, and intentions of people who matter – and we’ll prove it by showing you the titles of your respondents.

For additional questions about any of ISR’s reports or custom research services, please contact us at info@ISRreports.com.

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eTMF Preferences and Practices

Primary Section Takeaways
eClinical Technology Use
Preference for eTMF over Paper
Data Managed in eTMF
Use of TMF Solutions
Primary TMF Solution
Preferred Provider Agreements
Information Exchange Methods
Provide Sites with Remote Access
Areas of Innovation
Suggested Improvement
Added Functionality
Interest in New eTMF Features

eTMF Selection Drivers

Primary Section Takeaways
Most Important Selection Attributes
Most Important Satisfaction Attributes
Influence over eTMF Selection – Sponsor Perspective
Influence over eTMF Selection – CRO Perspective

eTMF Perceptions and Interactions

Primary Section Takeaways
eTMF Provider Familiarity
Leaders in the Field
eTMF Provider Usage
eTMF Provider Summary Table

eTMF Software Provider Performance and Loyalty

Primary Section Takeaways
A Note on Harvey Ball Calculations
Performance Across eTMF Software Providers
Figure 1 – Budget Factor
Figure 2 – Document Factors
Figure 3 – People Factors
Figure 4 – System Factors
Figure 5 – Usability Factors
Customer Loyalty

Study Data

Data Managed in eTMF – Today
Data Managed in eTMF – Future
Use of TMF Solutions – Today
Use of TMF Solutions – Future
Primary TMF Solution – Today
Primary TMF Solution – Future
Preferred Provider Agreements – Today
Number of Preferred Provider Agreements
Preferred Provider Agreements – Future
Third-Party eTMF Information Exchange

Investigator sites
IRBs/ethics committees
Regulatory authorities

Between sponsors and CROs
Provide Sites with Remote Access – Today
Provide Sites with Remote Access – Future
eTMF Use for Trial Process Improvement
Attribute Drivers in eTMF Selection
Most Important Attribute in eTMF Selection
Attribute Drivers in eTMF Satisfaction
Most Important Attribute in eTMF Satisfaction
eTMF vs. Paper TMF Preference
eTMF Selection – Sponsor Influence when Using a CRO
eTMF Selection – CRO Perception of Sponsor Influence
Departmental Decision-making Influence (Sponsor)
Departmental Decision-making Influence (CRO)
eTMF Software Provider Familiarity
Leaders in the eTMF Field
eTMF Provider Usage
eTMF Improvement – Themed
eTMF Improvement – Respondent Comments
eTMF Added Functionality – Themed
eTMF Added Functionality – Respondent Comments
Interest in Potential Additions to eTMF
Satisfaction with an eTMF Provider
Likelihood to Use an eTMF Provider Again
Likelihood to Recommend an eTMF Provider

eTMF Software Provider Drilldowns

Aurea (formerly NextDocs)
CareLex
Covance
EMC
Ennov
MasterControl
Medidata Rave eTMF
Montrium
Oracle
Phlexglobal
Safe-BioPharma
SureClinical
TransPerfect Trial Interactive
Veeva Vault
Wingspan Technology
WIRB-Copernicus/ePharmaSolutions

Respondent Demographics

Company type
R&D spend
CRO size
Primary area of responsibility
Respondent location
eClinical Technology Use
Types of eTMF solutions
Respondent age
Years in industry
Development phase involvement

Additional information

License

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