Wingspan – Wingspan eTMF

VENDOR: Wingspan Technology     

Wingspan Technology Inc
460 Norristown Road, Suite 200
Blue Bell, PA 19422, USA
Tel: +1 610 941 6500
http://www.wingspan.com/

DESCRIPTION OF eTMF SOLUTION

Wingspan eTMF was developed in partnership with the life sciences industry. Refined based on feedback from daily use by thousands of users from around the world, Wingspan eTMF has been used to facilitate a number of successful health authority inspections from a variety of agencies.

eTMF focuses on enabling a sponsor to maintain an up-to-date, inspection-ready eTMF throughout a trial in support of agency requirements. Our TMF Planning Wizards allow an organization to plan the expected documents for a specific study by creating placeholders for documents based on the specific characteristics of the study.

Wingspan eTMF supports the three critical-to-quality measures most important to eTMF management: completeness, quality and timeliness. By making use of CTMS integrations, we are able to assign due dates to TMF documents and thus report on completeness on an ongoing basis, not just completeness based on what is needed by the end of the trial. This allows the TMF to be kept in a contemporaneous manner, in accordance with recent guidance from MHRA and other agencies. Users control criteria for reports and metrics to obtain the exact information they need.

Completeness is evident pervasively throughout the system – missing and overdue documents are always evident and can be addressed in a timely manner. Documents can be uploaded and sent through QC, or can be directly imported into eTMF using pre-built scanning integrations. Documents can also be authored from templates, reviewed, and approved with or without electronic signature.

Wingspan eTMF includes all of the features needed to plan, maintain, monitor and close out TMFs. Close-out checks ensure that the TMF is lock-ready, and a complete export package can be generated to allow compliant transfer or archive of the TMF.

KEY FEATURES:

  • Proven history of successful health authority inspections
  • Scalability supporting hundreds of studies and thousands of users
  • Study planning tools that allow precise planning for each study
  • Integration tools support exchange of documents with a wide variety of electronic systems
  • Out of the box CTMS and scanning integrations
  • UAT package, training materials/session and system SOPs included
  • Special productivity tools to support CRAs
  • Dynamic generation of placeholders for new investigators, visits, etc.
  • Automated checks for study lock readiness and archive
  • Complete, compliant export package that includes content, metadata and audit trail

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