How Quality Review and Heatmaps Can Reduce Remediation Time, Cost, and Effort for an Acquired Trial Master File

May, 2022

Adapted from a Phlexglobal Ask An Expert interactive discussion, “How to Ensure TMF Inspection Readiness & ...

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Congratulations! You Just Acquired a Trial Master File. Now What?

April, 2022

Adapted from a Phlexglobal Ask An Expert interactive discussion, “How to Ensure TMF Inspection Readiness & ...

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Why Is the Trial Master File Critical in M&A activities?

March, 2022

Adapted from a Phlexglobal Ask An Expert seminar, “How to Ensure TMF Inspection Readiness & Compliance for a ...

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US FDA Provides Reminders for Upcoming eCTD Validation Changes

March, 2022

The DIA Regulatory Submissions, Information, and Document Management (RSIDM) Forum, held online and in person from ...

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How Phlexglobal has responded to Log4j vulnerability

December, 2021

At Phlexglobal, as we are made aware of new potential security vulnerabilities we rapidly assess the risk and take ...

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What Is the EMA DADI Project - and Why Is It Critical to IDMP, eCTD, RIM, and More?

December, 2021

If you are at all familiar with ISO IDMP (Identification of Medicinal Products), you are likely aware that this complex ...

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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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