In late-phase oncology, inspection readiness depends on how reliably teams can detect meaningful risk signals across large volumes of study data. In this collaboration, ADAMAS Consulting combined its QA expertise with Cyntegrity’s AI-augmented analytics to strengthen oversight across a global Phase III program.
Using the MyRBQM® Portal, ADAMAS applied targeted risk indicators to centrally review data from 50 investigator sites. Early signal detection enabled QA to focus on locations where data integrity or patient safety were most at risk—directly supporting the principles of ICH E6(R3).
This targeted approach helped the sponsor act sooner, prepare more effectively for inspection, and strengthen confidence in overall study quality.
Focused QA Where It Has the Most Impact
Risk indicators highlighted site patterns early, enabling QA teams to direct their efforts to high-value areas instead of conducting broad, low-return reviews.
Central Monitoring That Accelerates Corrective Action
Data anomalies and outliers surfaced sooner, allowing corrective steps to be initiated earlier in the study lifecycle.
Inspection Readiness in Complex Oncology Studies
Transparent, centralized insight supported a clearer rationale for QA decisions—strengthening inspection narratives and reducing pre-inspection workload.
Cyntegrity provides the AI-augmented RBQM technology through the MyRBQM® Portal.
ADAMAS contributes deep QA expertise and strategic guidance.
Together, they help oncology sponsors reduce oversight burden, detect issues earlier, and approach inspections with strengthened confidence.
ADAMAS Consulting used AI-supported RBQM analytics to prioritize QA focus across 50 sites, accelerating early risk detection and improving inspection readiness.
ADAMAS Consulting used AI-supported RBQM analytics to prioritize QA focus across 50 sites, accelerating early risk detection and improving inspection readiness.
Learn how ADAMAS supported a leading oncology sponsor using an AI-augmented, risk-based QA model.
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