TMF Risk-Based Quality Control: What Does this Really Mean?

August, 2020

Trial Master File (TMF) quality control is a topic that always seems to be present on conference agendas and it invokes ...

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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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AI Powered Automation Proven in Life Sciences

April, 2020

Adapted from a March 25, 2020 Phlexglobal webinar, “How Automation is Transforming Regulatory Compliance in Life ...

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10 Ways to Beat COVID-19 Stress

March, 2020

The next few months are going to be challenging in ways that we have never known. There are going to be different kinds ...

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Prepare yourself for 2020 – Global regulatory update

December, 2019

With an ever-increasing regulatory landscape, it is important to know what is coming next. Looking into regulatory ...

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Common Promotional Submissions in eCTD Errors and How to Avoid Them

November, 2019

Recently, the FDA held a free webinar in its CDER Small Business and Industry Assistance (SBIA) Webinar Series on “OPDP ...

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Highlights from the 2019 US TMF World Forum

November, 2019

In early October, Phlexglobal was honored to welcome industry TMF professionals from over thirty pharmaceutical ...

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