How to Close the “TMF Compliance Gap” with Advanced eTMF Archiving

June, 2021

Adapted from a Phlexglobal Innovation Tour webinar, “Crossing the TMF Compliance Gap with Inspection-Ready Access for ...

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How to Ensure Your Trial Master File's Audit Trail is Inspection-Ready

February, 2021

Regulatory agencies are increasingly looking at the TMF audit trail to gain greater insight into data integrity. We ...

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Achieving and Maintaining Sponsor Oversight of Outsourced Studies

September, 2020

Regulators have made it abundantly clear, through recent guidance and inspection findings, that compliance ...

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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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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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What To Know Before You Migrate a Trial Master File

July, 2019

Adapted from a March 2019 Phlexglobal webinar. For an in-depth look at the topic of migrating TMF data, view the ...

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EMA’s Trial Master File Guidance is in Effect. Are You Ready?

June, 2019

Adapted from an April 2019 Phlexglobal webinar presented by Eldin Rammell. For a more detailed discussion of the new ...

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