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Fran Ross

Fran brings more than 30 years of multi-faceted trial compliance expertise from the site, sponsor, consultant and CRO perspectives. As TMF Director at Advanced Clinical, she is focused on the principle that health authority regulations and expectations can be met without undue complexity. As a contributing member of the TMF Reference Model since 2009, Fran delivers a wealth of expertise in next generation TMF process and inspection surety projects. She relishes the renewed focus on risk management and quality by design upcoming in revision three of ICH E6 Good Clinical Practice.

Quality & Validation Technology Insights

Four Considerations for Implementing a Successful TMF Transformation Project
By Fran Ross on October 29, 2021

When you need a Trial Master File (TMF) transformation, whether it’s moving a paper TMF into a validated electronic repository or transferring a live trial’s eTMF from CRO to Sponsor,...

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