Karen Roy

Recent Posts

The Future of the TMF Reference Model

June, 2022

Adapted from a Phlexglobal Ask An Expert interactive discussion, “TMF Reference Model Q&A,” held April 6, 2022 and ...

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How Are Decentralized (Virtual) Trials Improving Clinical Efficiency?

June, 2021

On June 24, 2021, I was honored to moderate a dynamic roundtable discussion with an outstanding group of industry ...

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Updated FDA Guidance on Clinical Trial Conduct During COVID-19

May, 2020

On April 16, 2020, the US Food & Drug Administration (US FDA) released an update1 to its March 2020 guidance on the ...

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10 Short Years Ago, the TMF Reference Model Was Born

April, 2019

Almost exactly 10 years ago – on the 23rd of March, 2009 to be precise – a pretty diverse group of about 20 TMF ...

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