If you are evaluating RBQM, the key question is not “Will RBQM save money?”
but “How much of this value can we realistically capture, given our operating model?”
If you are evaluating RBQM, the key question is not “Will RBQM save money?”
but “How much of this value can we realistically capture, given our operating model?”
Reduction in on-site monitoring effort
Faster path to DB-lock
Avoidable cost exposure removed per study
Clinical teams today are under more pressure than ever: compressed timelines, rising complexity, and budgets that rarely stretch as far as they need to. Against that backdrop, RBQM is often presented as a cure-all. Understandably, many leaders push back: Does it truly save money, or is it just a polished slide deck promise?
Across sponsor and CRO programs, a clear pattern emerges:
when RBQM is treated as an operational discipline—not a software feature—the financial impact becomes surprisingly visible.
We see studies running with fewer surprises, cleaner data earlier, and monitoring resources used where they actually matter. Across Phase II/III programs, this consistently translates into meaningful reductions in avoidable work and tighter control of timelines.
The deeper figures—monitoring efficiencies, minimized rework, fewer amendments, and the knock-on effects on compliance—are shared in the downloadable case brief. So is the part most teams underestimate: how even small timeline gains can generate significant economic value for a product.
These aren’t promises or theoretical models. They’re patterns we’ve observed repeatedly in real RBQM programs where processes, governance, and people are aligned.
Monitoring & SDV Optimization (~ $1.5M)
RBQM enables targeted, data-driven allocation of CRA effort. It does not eliminate onsite visits—it makes them purposeful. For transparency, you can recreate all calculations with our Monitoring Cost Calculator.
Fewer Protocol Amendments (~ $250k)
RBQM strengthens protocol design through continuous feedback—supported by patterns reported in Tufts CSDD research and our own study experience. The reduction we see most often:
3.3 → 2.8 amendments per study
Operational Efficiency & Compliance (~ $300k)
RBQM strengthens audit readiness and reduces costly fire-drill reactions. Industry data shows responding to a single FDA warning letter can cost ~$300k.
RBQM reduces the probability of receiving one.
Timeline Acceleration & Market Access (~ $15M)
This is the most business-critical—and often the most conservative—impact. Even if you capture only the smallest item (1.5 weeks), the revenue impact is meaningful.
Early Risk Detection & Rework Prevention (~ $750k)
When deviations, missing endpoints, or safety signals are caught early, escalation loops shrink from months to days. This category is often underestimated but adds up quickly.
Design out avoidable risk before FPFV. AI-augmented protocol analysis surfaces CtQs, quantifies complexity, predicts deviation hot-spots, and reduces amendment drag, so you lock in patient-safe, inspection-ready design from day one.
Operationalize RBQM with verifiable math. AI-guided RACTs, calculation transparency, RBAC-secured workflows, and cross-study analytics deliver proportionate controls, clear KRI/QTL governance, and faster, defensible decisions at scale.
Move beyond manual cleaning and fragmented reviews. With time-series anomaly detection, protocol-aware deviation checks, and structured reasoning, the MyRBQM® Portal highlights what truly requires attention.
Stay ahead of issues, not behind them. Portfolio-wide, AI-enhanced dashboards fuse KRIs, QTLs, and deviation signals to cut escalation latency and focus monitors on high-value actions, fully aligned with ICH expectations.
See the full patient story—fast. Subject Profiles synthesize visits, AEs, ConMeds, labs, and trendlines, accelerating case review and improving safety decisions with transparent traceability and RBAC-controlled access.
Fast, secure connectivity with your clinical platforms through ready-made endpoints and low-overhead, real-time or batch data sync.
Pre-engineered, validated connectors to major EDC systems — reducing integration time while enabling secure, real-time or scheduled data sync.
Seamlessly connect your enterprise data platforms with secure, governed, low-overhead sync — without restructuring your existing data lake.
Our platform and processes meet internationally recognized security, availability, and confidentiality standards. ISO 27001:2022 certification and SOC 2 examinations provide independently verified assurance of our information security controls.
Our clinical-grade AI is independently certified through Microsoft’s Healthcare AI program, ensuring transparent, human-guided oversight, responsible AI practices, and secure integration with Azure’s validated infrastructure.
The MyRBQM Portal is built in alignment with 21 CFR Part 11 and GAMP 5, ensuring data integrity, traceability, and suitability for use in regulated clinical research environments.
If you are evaluating RBQM, the key question is not “Will RBQM save money?”
but “How much of this value can we realistically capture, given our operating model?”
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