eTMF

Complete. Consistent. Compliant.

“The Trial Master File (TMF) contains the evidence that patient rights and safety have been protected, and that the integrity of the trial data, study analysis, and study conclusions are credible.”

 

eTMF Logo

Do you have all the evidence for your clinical trial? In late 2010, Wingspan set out to create a completely new trial master file, one that would be dynamic, forward looking, and helpful in managing the trial process instead of simply cataloging documents received. Pharmaceutical companies have long dealt with the steep learning curve and inefficiencies of traditional TMF systems:

  • Complex folder hierarchies for TMF documents
  • Archane, complex indexing screens
  • No visibility into TMF completeness until after an audit has occurred
  • Unnecessary / unknown duplication of documents
  • Limited integration with CTMS Systems

Over 30,000 man-hours later, the team at Wingspan has developed the standard for TMF systems for years to come. With customizable dashboards, zero folder navigation, and a robust metrics system, Wingspan’s eTMF offers pharmaceutical companies and their study partners an unprecedented solution that supports their changing business models, avoids the problems of former electronic trial master files, and looks to the Cloud to help reduce total cost of ownership.

How can your company be sure it has all of the evidence for its clinical trials? Wingspan eTMF helps you ensure that your trials are complete, consistent, and compliant at all times.

Complete

  • Anticipate and track all the evidence/artifacts that are expected for a study
  • Account for artifacts at the Enterprise, Program, Study, Country, and Site levels

Consistent

  • Configuration of Wizard Questions and Answers generates a consistent set of artifacts required for studies conducted by your company
  • Indexing your documents is easy
  • Indexing a single document to multiple artifacts is streamlined
  • Quality Control Workflow provides management and document contributors with consistent answers to avoid confusion
  • eTMF supports the use of the DIA TMF Reference Model

Compliant

  • Track your documents for timeliness and make sure they are submitted before the next milestone
  • Generate reports for what TMF artifacts need to be reconciled with the Investigator Site File
  • 21 CFR Part 11 Ready

Additional Features and Benefits

  • Easy-to-use Dashboards by role
  • Easy integration to CTMS
  • Robust metrics system
  • Highly configurable
  • Wizard features for easy set-up
  • Maintenance features for simplified application management
  • Ability to set personalized views of the data

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