FDA Risk-Based Inspections: Move Risk Detection Upstream
FDA’s risk-based inspection approach raises a practical question: if protocol deviations and data anomalies can help regulators determine where to look, how can sponsors use related signals earlier – while there is still time to act?
Making RBQM Work in Practice: Adam Baumgart
What does it take to make RBQM work consistently in practice? Adam Baumgart discusses implementation, AI, cross-functional oversight and the customer experience required to turn risk signals into meaningful action.
Explainable AI in Clinical Trials
Clinical trial AI should do more than detect patterns. It must help teams understand, challenge, and document the rationale behind risk signals. Cyntegrity’s latest research reference explores how explainable mathematical discovery can support the next generation of RBQM innovation.
RBQM Explained: Why 100% SDV Falls Short in Clinical Trials
An educational excerpt from MyRBQM Essentials White Belt explaining why traditional monitoring and 100% Source Data Verification are no longer enough for modern clinical trial oversight.
Protocol Complexity and RBQM in Clinical Trials
New research shows protocol complexity continues to increase. Learn why Risk-Based Quality Management and AI-supported oversight are becoming essential.
Step into Nature: Moving for a Cause
Cyntegrity’s Step into Nature Challenge brought the Butterfly Challenge spirit to life through movement, teamwork, and charitable impact.
Service Level Availability – SLA
Service Level Availability or “SLA” means the targeted availability levels measured in the Production environment, as specified in the SaaS Listing which may vary according to each SaaS Offering and its component capabilities.
AI Literacy in Clinical Trials Under ICH E6(R3)
AI-supported workflows in clinical trials increasingly fall within GCP, computerized system, data integrity, and AI governance expectations. Sponsors and CROs need teams that understand oversight, validation, accountability, and responsible AI use.
FDA Warning Letter Highlights AI Oversight Risks in Clinical Trials
FDA’s warning letter signals a shift: AI use without oversight is a compliance risk. What clinical trial teams must understand to stay inspection-ready.
Global Uncertainty and Clinical Research: Why a Risk-Based Perspective Matters
Global risks in clinical trials are increasing as geopolitical instability, supply chain disruptions, and regulatory changes affect research worldwide. Learn why RBQM is essential for proactive oversight.
