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October 6, 2023

DIA 2023 Topic: The Industry-Wide Definition for RBQM

At the recent DIA 2023 Global Annual Conference, I focused my attention on discussions about the need for clear processes for reviewing audit trails, overseeing decentralized clinical trial (DCT) data, the impact of ICH E6(R3) on these areas, and the need for an industry-wide definition of Risk-Based Quality Management (RBQM).

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Decoding ICH E6(R3): What It Means for Risk-Based Quality Management (RBQM)

Authors: Frederic Blais, Jelena Pasimisina, Melissa Thomas ICH E6(R3) provides greater clarity on proactively designing quality...

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10 Steps for Practical RBQM Implementation for Your Business

Many clinical trial Sponsors and Contract Research Organizations (CROs) realize the great benefits of Risk-Based Quality...

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QTLs: Where Are We, And How Much Further Can We Go?

Quality Tolerance Limits (QTLs) represent a significant advancement in clinical trial research, aimed at proactively identifying...