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Denis Katz
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Denis Katz Clinical Consultant
For decades, central nervous system (CNS) disorders have been defined primarily through observable symptoms rather than measurable biology. Conditions such as major depressive disorder, Alzheimer’s disease, and Parkinson’s disease were historically grouped into broad syndromic categories because the underlying mechanisms driving disease were poorly understood.
https://salienceclinical.com/

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Precision Neurology 2026 From Syndromes to Signatures: The Strategic Rewiring of CNS Drug Development | #facerelation

Precision Neurology 2026 From Syndromes to Signatures: The Strategic Rewiring of CNS Drug Development

Precision Neurology 2026 From Syndromes to Signatures: The Strategic Rewiring of CNS Drug Development

CNS disorders are now being reclassified through molecular signatures, circuit-level dysfunction, and digital phenotypes. This shift is not a technological upgrade—it is a strategic reset. Sponsors who continue to build programs around broad diagnostic categories and legacy endpoints wil
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  • https://www.linkedin.com/in/denis-k-medaffairs/

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RBQM is now the prevailing approach to clinical trial oversight in regulated drug, biologic, and device development. The core idea is proportionality: monitoring intensity and quality controls are aligned to the risks that matter for subject safety and decision-making endpoints, rather than applying uniform, resource-intensive methods such as blanket 100% source data verification. RBQM centers on identifying Critical-to-Quality (CtQ) factors, establishing Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs), and using centralized analytics and targeted on-site activities to address high-priority issues.

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