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

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

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Overcoming TMF Artificial Intelligence Challenges

Adapted from a Phlexglobal Innovation Tour webinar, “Streamlining TMF Documentation through Clinical Automation,” held ...

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

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

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AI Advances in Life Sciences Regulatory: 2020 Review and 2021 Expectations

Artificial Intelligence (AI) continues to make strides in the life sciences regulatory arena, but many obstacles ...

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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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