Don't Just Buy Apps.
Build Ecosystems.
Dashboards are passive. Ecosystems are active. I architect closed-loop data environments where risk signals don't just sit in a report—they trigger automated workflows in your CTMS, ensuring your CRAs act on the data we find.
Risk Signal Flow
How risk signals flow through your clinical trial ecosystem—from data collection to actionable insights.
RBQM Platform
Central Risk Analytics
EDC System
Data Collection
Patient data, visits, assessments
ePRO/eCOA
Patient Reported
Quality of life, symptoms, compliance
Safety Database
Pharmacovigilance
AEs, SAEs, safety signals
Reporting Layer
Decision Support
Dashboards, reports, insights
EDC System
Data CollectionPatient data, visits, assessments
ePRO/eCOA
Patient ReportedQuality of life, symptoms, compliance
RBQM Platform
Risk AnalyticsKRI calculation, trend analysis, risk scoring
Safety Database
PharmacovigilanceAEs, SAEs, safety signals
Reporting Layer
Decision SupportDashboards, reports, insights
THE "CENTRAL INTELLIGENCE" ARCHITECTURE
A unified Clinical Data Warehouse (UCDW) that acts as the single source of truth, connecting your disconnected vendors into a synchronized intelligence engine.
CORE
Strategy
Defining the Protocol Risk Assessment and Critical Data Points.
We start by mapping the protocol to identify what truly matters. This isn't just a document; it's the blueprint for the entire data strategy.
VALUE FOR EVERY STAKEHOLDER
"Actionable Oversight"
I ensure your CRAs actually act on the data we find. No more risk signals dying in a PDF report. We push tasks directly to their CTMS workflow.
"Single Source of Truth"
I build robust, compliant data warehouses that act as a single source of truth for all your vendors. Automated ETLs, standardized models, and secure APIs.
"Audit-Ready Compliance"
I provide a closed-loop audit trail that demonstrates full oversight to the FDA/EMA. From signal detection to resolution, every step is timestamped.
Technology Enablement Partners
ALREADY HAVE A PLATFORM?
I don't just build custom apps. I help you maximize the ROI of your existing investments.
CluePoints & Clinical Data Studio
Expert implementation and configuration services. I help you enable these powerful systems within your current processes, ensuring they aren't just "shelf-ware."
- System Configuration & Validation
- KRI/QTL Library Setup
- Team Training & Change Management
Process Re-Engineering
Technology fails without process. I align your SOPs and monitoring plans to leverage the automation capabilities of modern RBQM tools.
- SOP Updates for ICH E6(R3)
- Central Monitoring Workflow Design
- Cross-Functional Role Definition