RBQM Strategy & Implementation
End-to-end RBQM design, protocol risk assessment, RACT facilitation, and KRI framework development.
Key Capabilities
- Protocol risk assessment & RACT facilitation
- RBQM plan development (ICH E6 R3 compliant)
- KRI design & threshold setting
- Risk categorization frameworks
- Quality tolerance limits definition
Two Ways to Work Together
Staff Augmentation
I join your team to lead RBQM strategy using your existing processes and governance frameworks.
Solution Delivery
I deliver a complete RBQM implementation package with templates, KRI library, and training materials.
Data Analytics & Dashboard Development
Custom dashboards, business intelligence, and clinical data visualization using R Shiny, Power BI, or your preferred tools.
Key Capabilities
- Custom R Shiny dashboard development
- Power BI ecosystem design & optimization
- Clinical data visualization & reporting
- Automated data reconciliation scripts
- Real-time KRI monitoring dashboards
Two Ways to Work Together
Staff Augmentation
I build dashboards and analytics using your existing tools (Spotfire, Tableau, Power BI, or internal platforms).
Solution Delivery
I deliver custom R Shiny or Power BI solutions with full documentation, training, and handover.
Platform Adoption & Training
RBQM platform optimization, team training, change management, and vendor coordination for Medidata, Veeva, Oracle, and other systems.
Key Capabilities
- Medidata/Veeva/Oracle RBQM platform configuration
- Team training & adoption strategies
- SOP development & process documentation
- Vendor coordination & requirement translation
- Change management & stakeholder alignment
Two Ways to Work Together
Staff Augmentation
I embed with your team to drive platform adoption, train users, and ensure your RBQM technology actually gets used.
Solution Delivery
I deliver training programs, adoption playbooks, and SOPs tailored to your platform and processes.
Data Quality & Validation
Database cleaning, GAMP5 validation, CSV documentation, and quality assurance for clinical systems.
Key Capabilities
- Database cleaning & data reconciliation
- GAMP5 risk-based validation (CSA approach)
- CSV documentation & test script development
- Quality assurance frameworks
- Regulatory compliance support
Two Ways to Work Together
Staff Augmentation
I work as your data quality contractor to clean databases, validate systems, and ensure regulatory compliance.
Solution Delivery
I deliver validation packages, CSV documentation, and QA frameworks ready for regulatory inspection.
Not Sure Which Approach Fits Your Needs?
Let's discuss your project. I'll help you determine whether staff augmentation or solution delivery makes more sense for your timeline, budget, and goals.