Vendor RBQM Platforms Are Pricing You Out.
Major RBQM vendors charge $50K-$150K per study for platform access. For smaller biotech companies running 3-5 studies simultaneously, that's $150K-$750K annually—just for software licensing. Add implementation fees, training costs, and ongoing support, and you're looking at $1M+ in RBQM technology spend before you've enrolled a single patient.
The platforms work. But the pricing model doesn't scale for sponsors with limited budgets or academic institutions conducting investigator-initiated trials.
Common Pain Points:
- ●Per-Study Pricing: Costs multiply with every new trial
- ●Vendor Lock-In: Switching platforms mid-program is prohibitively expensive
- ●Limited Customization: One-size-fits-all dashboards don't address therapeutic area-specific needs
- ●Validation Overhead: Each platform upgrade requires revalidation
Build Once. Own Forever. Use Across All Studies.
We build custom RBQM dashboards using R Shiny and Power BI—validated to 21 CFR Part 11 and compliant with ICH E6(R3). You pay a fixed project fee, then deploy the solution across unlimited studies. No per-study licensing. No vendor lock-in. You own the code.
Fixed Project Pricing
One-time build cost. No recurring per-study fees. Ideal for sponsors running multiple trials.
Fully Validated
21 CFR Part 11 validation documentation, test scripts, and audit trail included.
You Own the Code
Full source code handover. Modify, extend, or maintain internally without vendor dependency.
What We Build:
Custom R Shiny Dashboards
Study-specific RBQM dashboards with KRI tracking, site performance monitoring, and safety signal detection. Fully interactive and web-based.
Power BI Solutions
Enterprise-level RBQM dashboards that integrate with your existing Microsoft ecosystem (Azure, SQL Server, SharePoint).
Data Integration Pipelines
Automated ETL pipelines to pull data from EDC, CTMS, ePRO, and Safety databases. No manual exports.
Validation Documentation
Complete validation package: Requirements Traceability Matrix (RTM), test scripts, User Acceptance Testing (UAT) protocols, and audit trail configuration.
Regulatory Compliance: All solutions are designed to meet ICH E6(R3) requirements for risk-based quality management and FDA 21 CFR Part 11 for electronic records and signatures.
Real Results: Mid-Size Biotech Saves $400K Annually
A mid-size biotech company with 5 active Phase II/III trials was facing $600K in annual RBQM platform licensing fees. They engaged us to build a custom R Shiny dashboard that could replace their vendor platform.
Project Outcome:
From kickoff to validated deployment
Eliminated per-study licensing fees
Passed FDA inspection with zero findings
Team preferred custom dashboard over vendor platform
"We were spending more on RBQM software than on our CRO. The custom R Shiny dashboard gave us everything we needed—KRI tracking, site performance monitoring, safety signal detection—at a fraction of the cost. And we own it."
— VP of Clinical Operations, Mid-Size Biotech
Calculate Your Potential Savings
See how much you could save by switching from vendor platforms to a custom RBQM solution.
RBQM ROI CALCULATOR
Estimate the financial impact of transitioning from traditional monitoring to Risk-Based Quality Management.
Study Parameters
Cost Assumptions
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* Estimates based on industry averages: 25% reduction in on-site monitoring visits.
When to Choose Custom vs. Vendor Platforms
Choose Tailored Solutions If:
- You're running 3+ studies simultaneously
- Per-study licensing fees exceed your budget
- You need therapeutic area-specific customization
- You want to own the code and avoid vendor lock-in
- You have internal IT/data science resources for maintenance
Choose Vendor Platforms If:
- ●You're running 1-2 studies and budget isn't a constraint
- ●You need immediate deployment (vendor platforms are pre-validated)
- ●You lack internal resources for dashboard maintenance
- ●You prefer vendor-managed updates and support
- ●Your CRO already uses a specific platform
FREQUENTLY ASKED QUESTIONS
How much does a custom RBQM dashboard cost compared to vendor platforms?
A typical custom R Shiny or Power BI dashboard costs $80,000-$150,000 for initial development and validation, with $15,000-$30,000 in annual maintenance. In contrast, vendor platforms like Medidata or Veeva charge $50,000-$150,000 per study annually. If you're running 3+ studies simultaneously, custom development typically achieves ROI within 12-18 months. Use our ROI Calculator above to model your specific scenario.
How long does it take to build and validate a custom RBQM dashboard?
Our typical timeline is 8-12 weeks from kickoff to validated deployment: (1) Discovery & requirements gathering (1-2 weeks); (2) Dashboard development & data integration (4-6 weeks); (3) User acceptance testing (1-2 weeks); (4) Validation & documentation (2-3 weeks). This assumes your data sources (EDC, CTMS, Safety DB) have accessible APIs or data exports. Complex integrations may add 2-4 weeks.
Can a custom dashboard be validated for GxP compliance?
Yes. We follow Computer System Validation (CSV) principles aligned with GAMP 5 and 21 CFR Part 11. Our validation package includes: User Requirements Specification (URS), Functional Specification (FS), Design Specification (DS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Traceability Matrix. We've successfully passed FDA inspections with zero validation findings on custom dashboards.
What happens if we need to modify the dashboard after deployment?
Because you own the code, modifications are straightforward. Minor changes (e.g., adjusting KRI thresholds, adding new visualizations) can be implemented in days. Major changes (e.g., integrating a new data source, adding predictive analytics) require impact assessments and partial re-validation. We provide source code documentation and knowledge transfer so your internal team can make simple updates independently, or we can provide ongoing support under a maintenance agreement.
Do we need internal IT resources to maintain a custom dashboard?
It depends on your maintenance expectations. For basic operations (running the dashboard, generating reports, adjusting thresholds), no specialized IT resources are required—clinical operations teams can manage this. For technical updates (bug fixes, new features, data integration changes), you have two options: (1) Engage us for ongoing support ($15K-$30K annually), or (2) Build internal capability by training your data science or IT team. We provide comprehensive documentation and knowledge transfer to support either approach.
How Solution Delivery Works
Requirements
Define scope and success criteria
Design
Architecture and technical planning
Build
Development and configuration
Test
Validation and quality assurance
Deploy
Go-live and implementation
Train
Team enablement and handoff
Requirements
Define scope and success criteria
Design
Architecture and technical planning
Build
Development and configuration
Test
Validation and quality assurance
Deploy
Go-live and implementation
Train
Team enablement and handoff
Related Services
Explore complementary services that work well together
Staff Augmentation
Fill critical RBQM capacity gaps with embedded experts who own and execute. From RBQM Leads to Clinical Technology Architects.
System Analysis
Optimize your existing RBQM platform with configuration, training, and adoption strategies that ensure teams actually use the technology.
Validation
Risk-based validation (CSA), test scripts, and 21 CFR Part 11 compliance documentation for your custom RBQM solutions.