This onboarding plan provides a high-level, customer-agnostic view of how MyRBQM® Portal implementations typically progress — from initial alignment to hypercare and scale-up. It is designed to give study teams, clinical operations, data management, and governance functions a shared understanding of what an effective RBQM roll-out can look like.
Actual activities, durations, and responsibilities vary by solution scope, operating model, system readiness, and the level of documentation available. Most new customers complete initial onboarding within three to six months, depending on specifications, integrations, and cross-functional alignment.
We operate seamlessly across in-house, hybrid, and outsourced delivery models, tailoring each implementation to your objectives and value drivers.
Pilot Phase Foundations
Operational and data-flow alignment
Study and workflow prioritization
Core configuration and out-of-the-box integration
Readiness for validation and compliance
Targeted user enablement and support pathways
Integration & Innovation Enhancements
Extension to multiple studies
Portfolio-level insights
Enhanced automation and AI-augmented data review
Continuous improvement and operational refinement
Institutional Governance
Embedded, audit-ready RBQM workflows
QbD and CtQ metrics integrated across R&D
Enterprise-wide consistency, visibility, and scalability
Every rollout becomes a shared journey. Your teams stay in the driver’s seat while we bring the structure, clarity, and momentum to make RBQM work in practice.
People
Your teams build capability fast through MyRBQM® Academy pathways—practical, role-based learning that supports confident adoption.
Process
We help translate ICH E6(R3) expectations into workable RBQM routines—strengthening your SOPs and supporting protocol design with AI-enabled complexity assessment, so study teams know exactly how to apply risk thinking from day one.
Platform
Our solution architects configure analytics, integrations, and workflows around your environment—minimizing lift for your teams and aligning to the systems you already trust.
Governance
Together, we establish a transparent oversight model that aligns sponsors, CROs, and partners while keeping responsibility where it belongs.
Estimate Your Cost Savings
Get a quick, directional view of how risk-based quality management can reduce monitoring effort, rework, and delay-related costs in your next study.
Estimate Your Cost Savings
Get a quick, directional view of how risk-based quality management can reduce monitoring effort, rework, and delay-related costs in your next study.
This plan is designed for:
Sponsors adopting RBQM for the first time
Organizations scaling from pilots to portfolio-level oversight
CROs supporting sponsor roll-outs
Digital transformation, clinical operations, QA, and data management leaders
Get the full MyRBQM® Portal Onboarding Plan and see how a structured rollout takes shape — from early alignment and validation readiness to integration pathways, governance setup, and the transition into hypercare. The guide outlines how each workstream matures over the first months so you know exactly what to expect and how to prepare your teams for a smooth, inspection-ready start.
If you’d like to discuss how this onboarding plan applies to your studies, our Growth team is the best place to start.
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