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Amid the recently released ICH E8 (R1) draft guidelines further supporting RBM strategies, practical methods for integrating critical-to-quality (CTQ) factors within the operational execution life cycle of a clinical trial are presented.
Brian Barnes
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Articles by Brian Barnes
Using a risk-based model to navigate the inherent changes and fluctuations in master protocol studies-and help maintain data integrity throughout.
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Latest Updated Articles
De-risking Master Protocol ImplementationPublished: June 1st 2019 | Updated:
![PPD figure 2[1].png](https://cdn.sanity.io/images/0vv8moc6/act/209e92e4f679d2a1d42544312ce717b002bbe8eb-838x382.png?w=300&fit=crop&auto=format)
Risk-Based Quality Management: The Importance of Risk CommunicationPublished: June 19th 2019 | Updated:
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