The Four Vectors.
We organize our services into four distinct vectors: Strategic Architecture (The Plan), Tailored RBQM Solutions (The Build), Platform Enablement (The Adoption), and The Validation Vector (The Compliance).
Our Approach: Discovery & Strategy (1-2 weeks) → Implementation & Build (3-4 weeks) → Adoption & Training (Ongoing)
Strategic Architecture
Helping you define what matters before the first patient is screened.
RBQM Design & RACT
Facilitated risk assessment workshops to identify critical data and processes.
Protocol Risk Assessment
Stress-testing your protocol design against real-world data challenges.
System Gap Analysis
Mapping the disconnects between your EDC, CTMS, and Safety systems.
Audit Preparation
Mock inspections to ensure your risk management documentation is inspection-ready.
Tailored RBQM Solutions
Cost-effective custom dashboards as alternatives to expensive per-study vendor pricing.
Custom R Shiny Dashboards
Validated, compliant RBQM dashboards priced per project, not per study. Perfect for cost-conscious sponsors.
Power BI Solutions
Enterprise-level RBQM dashboards that integrate with your existing data infrastructure.
21 CFR Part 11 Validation
All custom solutions include full validation documentation and audit support.
Fixed Project Pricing
No per-study fees. One-time build cost, then you own it. Ideal for smaller biotech and academic institutions.
Platform Enablement
Bridging the gap between technology and adoption. We ensure your teams actually use the platforms you've purchased.
Platform Configuration
Expert configuration for Medidata, Veeva, Oracle, and other RBQM platforms. We optimize your setup for maximum adoption.
Role-Based Training
Customized training for Data Managers, Medical Monitors, CRAs, and Safety Physicians. We teach your teams how to leverage RBQM platforms effectively.
Change Management
Adoption strategies that reduce resistance and increase platform utilization. We help you overcome the "adoption gap."
Ongoing Support
Retainer-based support to sit in your data review meetings, answer questions, and guide interpretation.
The Validation Vector
GxP Compliance, Accelerated. Risk-Based Validation (CSA) for your RBQM tools.
Validation Plan (VP)
Defining the strategy and risk assessment (CSA approach) for your specific configuration.
IQ/OQ/PQ Scripts
Pre-written test script libraries customized to your workflow.
Traceability Matrix
Linking every regulatory requirement (21 CFR Part 11) to a test result.
Validation Summary Report
The final "Green Light" document for your TMF, signed and inspection-ready.
Efficiency_Metric: Speed_to_Go_Live
INITIALIZE YOUR VECTOR.
Select your engagement model to begin transformation.