RISK-BASED QUALITY MANAGEMENT

Where Innovation Works. At Scale.

OUTCOMES

Increasing the Odds  of Success

Your trial’s success depends on the confidence you have in its design, data, and decisions. With Cyntegrity’s AI-augmented Risk-Based Quality Management (RBQM), you can strengthen human judgment by keeping every decision traceable, helping your teams understand not only what changed, but why. From meeting ICH E6(R3) and E8(R1) expectations to connecting data sources and spotting risks earlier, you gain oversight that scales with your portfolio and budget.

Engineered with compliance-first logic

Three Risks Execs Eliminate First

Global Oversight Gaps

You’re steering a multi-region portfolio with many moving parts. Get one live view of risk so you can act earlier, align QA/ClinOps, and keep every study on track.

Delayed Risk Detection

Lean team, big stakes. Turn live signals into early alerts so issues are fixed  before they become findings, without adding headcount.

Sponsor Confidence at Risk

Be the partner sponsors trust. Deliver transparent oversight and audit-ready  reporting on demand, while hitting timelines at a competitive cost.

Model Your Monitoring Effort

A quick assessment to gauge the impact of transitioning from 100% SDV to risk-based quality management.

Trusted to Protect What Matters

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Availability SLA

$ 0 M

Saved/Study

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Organizations

Change Management? Fundamentals in 7 Hours.

Our RBQM Essentials Belt gives your study teams the skills, mindset, and shared risk-based quality management vocabulary they need before go-live.

2,000+

Learners

7h

On-demand

RBQM BELT

Certificate

Change Management? Fundamentals in 7 Hours.

Over a Decade of Scientific Impact

Want to help build what comes next?

Pioneered ML Risk Signals

AI-Supported RBQM Workflows

“Ask AI” for Medical Oversight

ICH E6(R3)/E8(R1)-Aligned AI Oversight

2013

2020

2023

2025

2013

Pioneer in ML Predictive Analytics for RBQM

2020

Study-wide Risk Predictions

2023

Agentic RBQM AI Anomaly Detection

2025

Sequentioal RBQM Agentic AI Personas

Ready to Explore RBQM Together?

We’d be glad to walk through your RBQM goals and discuss how decision-focused oversight can support quality, compliance, and scale under ICH E6(R3).

RISK-BASED QUALITY MANAGEMENT

Where Innovation Works. At Scale.

Increasing the Odds  of Success

Engineered with compliance-first logic