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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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Leveraging RBQM In Ways You Never Envisioned

Risk-Based Quality Management (RBQM) is fast becoming a staple in clinical research, and the community is...

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Risk-Based Study Execution (RBx) – It’s Time To Close The Loop!

Transforming RBQM into Proactive Quality Actions When the journey began, the focus was clear: monitoring. The...

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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...