Wingspan offers eTMF Readiness Assessment


Applied Clinical Trials

BLUE BELL, PA --- Wingspan Technology now offers an eTMF Readiness Assessment program to help sponsors and CROs assess their level of readiness for implementing eTMF. Completion of the Readiness Assessment will help organizations to learn about best practices, identify gaps, plan resource needs, and move towards risk-based decision making. The assessment can be tailored to best support an organization based on its size, previous experience, partnering approach, and more.

The process begins with a workshop that focuses on reviewing lessons learned from relevant case studies and discussing key elements of eTMF readiness with a cross-functional team. Wingspan’s experts facilitate the discussion, emphasizing the impact that decisions made in early project phases will have in optimizing processes, increasing efficiency and decreasing regulatory risk.

The organization then completes a detailed questionnaire covering 11 key aspects of eTMF readiness. Wingspan analyzes the responses and produces a report interpreting the results,

benchmarking the organization against industry wherever possible, and providing prioritized recommendations for areas of emphasis and return on investment. The resulting report is reviewed in a meeting or teleconference.

“Sponsors and CROS often find it challenging to decide where to focus their attentions when moving from a paper TMF or a traditional “repository” eTMF to a modern, actively managed eTMF,” said Kathie Clark, Wingspan’s Vice President of Product Management.

“There are so many decisions to make, with the impact often being unclear. Understanding the characteristics that mature organizations display with respect to eTMF allows organizations newer to eTMF to assess gaps, make fact-based decisions, and optimize use of their available budget and resources.” 

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