A Proven Process for RBQM Success.
Our structured approach to Risk-Based Quality Management has been refined through dozens of implementations across Phase I-IV trials. Each step builds on the previous, creating a comprehensive quality ecosystem that protects data integrity and patient safety.
Typical Implementation Timeline
From kickoff to operational RBQM in 8-12 weeks
Deep Dive: Each Phase Explained
Click on any phase to expand and see detailed activities, tools used, and team involvement for each step of our RBQM implementation process.
Frequently Asked Questions
How long does a typical RBQM implementation take?
From kickoff to operational monitoring, most implementations take 8-12 weeks. This includes risk assessment (2-4 weeks), KRI design (2-3 weeks), and platform configuration (3-6 weeks). Some phases can run in parallel to compress the timeline.
What if we already have an RBQM platform but it's not working well?
We frequently help sponsors optimize existing implementations. We can assess your current setup, identify gaps, recalibrate thresholds, and retrain teams—often achieving significant improvements within 4-6 weeks.
Do you work with all RBQM platforms?
Yes. We have deep experience with Medidata Detect, CluePoints, Veeva Vault CTMS, Oracle Argus, and custom R-Shiny solutions. We're platform-agnostic and focus on what works best for your specific needs and existing infrastructure.
What level of involvement do we need from our internal team?
We handle the heavy lifting, but successful RBQM requires input from your Medical, Clinical Ops, Data Management, and Biostatistics teams. Expect 2-4 hours per week from key stakeholders during implementation, less during operations.