Achieving and Maintaining Sponsor Oversight of Outsourced Studies

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

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Innovations In IDMP Preparation: Perspectives from Sponsors

Adapted from the Phlexglobal Innovation Tour virtual panel discussion, “Innovation on IDMP / Data Preparation,” held ...

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

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

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

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

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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