|Articles|September 23, 2015

Wingspan eTMF Adds TMF Reference Model Browser

BLUE BELL, PA --- Wingspan Technology’s industry-leading eTMF now offers the ability for a user to browse any study in the TMF Reference Model Version 3 structure. The Reference Model browser allows a trial to be viewed in a tree structure based on the Reference Model zone, section and artifact. Any user can choose to view a study in this structure, even if it was created in an earlier version of the Reference Model or if the organization has modified the Reference Model to meet their requirements. A user can switch between this view and Wingspan’s powerful consumer-style filter navigation with a single click. The TMF Reference Model Browser provides a number of advantages over a traditional folder structure:

Clicking on any level will display a roll-up of all documents under that level. For example, clicking on the Safety Zone will show all documents across sections and artifact types within that zone. Traditional folder views would always show empty folders at the Zone and Section levels. The structure can be filtered to show specific countries and sites. As a result, it becomes much more usable than traditional folders in large studies with dozens of countries and hundreds of sites, which would otherwise result in hundreds of documents in each folder.

  • Because the structure is created dynamically, it will never contain empty folders.

  • The structure is easily updated by the organization’s own Business Administrators when the Reference Model changes or an organization makes its own changes to taxonomy. Changes can be made without modification to existing documents.

“Sponsors and who have committed to using the TMF Reference Model are now faced with the challenge of incorporating the best practice changes in the new Version 3,” said Kathie Clark, Wingspan’s Vice President of Product Management. “Wingspan’s TMF Reference Model browser means that they can upgrade their eTMF, even during an ongoing trial, and still see a unified presentation of a specific Trial Master File.”


Related to this article

The Human Side of Clinical Trials: How Measuring Readiness at Training Predicts Trial Risk Before It Shows Up in the Data
This episode of The Human Side of Clinical Trials, hosted by Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., explores why training completion metrics like attendance and quiz scores fail to capture true study readiness, and how measuring both competence and confidence can reveal trial risks before enrollment even begins.
What the Epilepsy Community Has Taught Us About Trial Feasibility
In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, shares what she has learned firsthand from families living with Dravet syndrome and CDKL5 deficiency disorder about what makes trial participation possible—and what makes it not.