Choosing the right Risk-Based Quality Management (RBQM) platform is now a critical decision for sponsors and CROs, especially as ICH E6(R3) emphasizes proportionate, data-driven, and traceable oversight.
The right system should not only monitor risk — but enable teams to understand, anticipate, and act on it.
Below are five essential evaluation questions, and how the MyRBQM® Portal addresses each one.
Look for:
Versioned datasets
The ability to see what was known when
Decision traceability over time
How MyRBQM® Helps:
Every data point is time-versioned, allowing teams to review historical study states, compare iterations, and understand how decisions evolved.
Example: View site performance trends across weeks or quarters — not just snapshots.
A compliant RBQM system must support source traceability, ensuring you can justify decisions during audits or regulatory review.
How MyRBQM® Helps:
Each value carries three timestamps:
When the data was originally recorded
When it entered the system
When it was used in analysis
This means no ambiguity and no gaps in the decision context.
Risk decisions must be explainable. Regulators are increasingly expecting teams to demonstrate not only what changed, but also why.
How MyRBQM® Helps:
All transformations — from source refresh to derived metrics — are logged and reproducible.
You can re-run analyses exactly as they were, even months later.
This supports clean inspection narratives and smooth regulator interaction.
Clinical programs generate large, evolving data streams. Your RBQM system must perform reliably under load — not just in static report mode.
How MyRBQM® Helps:
The platform is designed for high-volume, continuous ETL and analysis, featuring efficient query execution and resilient processing pipelines.
This ensures stable performance — even at scale, across global portfolios.
RBQM is cross-functional, encompassing Medical, Operations, Data, QA, and Vendors.
Systems must reflect this reality.
How MyRBQM® Helps:
Stakeholders can work simultaneously with shared visibility and role-based permissions, ensuring alignment and eliminating duplicated review cycles.
Selecting an RBQM platform is not just a technology decision — it affects your inspection readiness, operational efficiency, and patient safety outcomes.
A system designed for transparency, verifiability, auditability, collaboration, and performance allows sponsors and CROs to manage study risk with confidence.
That is the foundation of the MyRBQM® Portal — and why it remains the trusted choice for BioPharma organizations scaling modern clinical research portfolio complexity.
Not all RBQM is truly traceable.
Most platforms monitor risk — very few explain why decisions were made.
Regulators care about the decision trail, not the dashboard.
Not all RBQM is truly traceable.
Most platforms monitor risk — very few explain why decisions were made.
Regulators care about the decision trail, not the dashboard.
Selecting an RBQM system is not just about current dashboards—it is about whether decisions remain explainable months or years later. This short paper explores why historical context, traceability, and longitudinal auditability matter when comparing RBQM platforms, and how expert systems differ from rule-based tools.
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