Technical Capabilities
Tools & Platforms Expertise
15+ years of hands-on experience implementing, configuring, and building RBQM solutions across commercial platforms and custom analytics tools. I speak the language of both clinical operations and software engineering.
Platform Expertise
Your Clinical Data Ecosystem
We integrate across your entire technology stack, ensuring data flows seamlessly from collection to insight.
EDC Systems
- Medidata Rave
- Veeva Vault
- Oracle Clinical One
RBQM Tools
- Medidata Detect
- CluePoints
- Clinical Data Studio
Safety & Quality
- Safety Database
- CAPA Systems
- Audit Management
Reporting & Analytics
- Power BI
- R Shiny
- Spotfire
Vector Quality Sciences: Your Integration Layer
EDC Systems
- Medidata Rave
- Veeva Vault
- Oracle Clinical One
RBQM Tools
- Medidata Detect
- CluePoints
- Clinical Data Studio
Safety & Quality
- Safety Database
- CAPA Systems
- Audit Management
Reporting & Analytics
- Power BI
- R Shiny
- Spotfire
Commercial RBQM Platforms
Platform enablement, custom configuration, and user training for enterprise RBQM systems
Medidata Rave RBQM
8+ years, 10+ implementations
KRI library design and custom metric development
Study Risk Evaluation Plan (SREP) configuration
Integration with Rave EDC and Rave Safety Gateway
User training for CRAs, data managers, and quality teams
Dashboard customization and report automation
Veeva Vault CTMS + Quality
5+ years, 6+ implementations
Quality event tracking and CAPA workflow configuration
Risk indicator mapping to CTMS milestones
Custom object creation for RBQM-specific data
Integration with Veeva Vault EDC
Report and dashboard development
Oracle Clinical One (Siebel CTMS)
7+ years, 8+ implementations
Site performance KRI development
Custom data extracts for external analytics
Integration with Oracle InForm EDC
Workflow automation for quality oversight
User adoption strategies and training
CluePoints
4+ years, 5+ implementations
Statistical KRI configuration and threshold tuning
Central monitoring workflow optimization
Integration with EDC systems (Medidata, Oracle, others)
User training for statistical monitoring teams
Custom report development
Custom Analytics & Dashboards
Building bespoke RBQM solutions when commercial platforms don't fit your ecosystem
R Shiny
10+ years, 15+ custom applications built
Primary tool for custom RBQM solutions
Full-stack RBQM application development
Real-time data integration (EDC, ePRO, Safety DB, IRT)
Advanced statistical modeling and predictive analytics
Role-based dashboards (CRA, data manager, executive)
Deployment on AWS, Azure, or on-premise servers
Power BI
8+ years, 20+ dashboards deployed
Best for executive-level portfolio views
Portfolio-level executive dashboards
KRI visualization and trend analysis
Integration with Microsoft Fabric data lakes
Drill-through navigation from portfolio to site level
Automated refresh and email distribution
Tableau
6+ years, 12+ implementations
Interactive risk dashboards
Site performance benchmarking
Data blending from multiple sources
Mobile-responsive dashboard design
Tableau Server deployment and governance
Python (Streamlit, Dash)
8+ years, 10+ applications
Rapid prototyping of RBQM concepts
Machine learning model deployment
Data quality reconciliation tools
API development for system integrations
Automated reporting pipelines
Data Integration & ETL
Connecting disparate clinical trial systems into unified RBQM ecosystems
EDC Systems
12+ years across all major EDC platforms
Medidata Rave (API, MQL, CDASH extracts)
Oracle InForm (web services, database views)
Veeva Vault EDC (REST API)
OpenClinica (REST API, database access)
Custom EDC systems (database connectors)
ePRO & eCOA Systems
8+ years, 15+ integrations
Signant Health (API integration)
CRF Health (data extracts)
YPrime (API, SFTP)
Custom ePRO vendors (proprietary APIs)
Data reconciliation with EDC
Safety Databases
10+ years, 12+ integrations
Oracle Argus (database views, web services)
ArisGlobal (API integration)
Veeva Vault Safety (REST API)
Custom safety databases (SQL connectors)
Automated AE reconciliation with EDC
Data Warehousing
12+ years, 25+ implementations
PostgreSQL (primary choice for custom solutions)
Microsoft SQL Server
MySQL / MariaDB
Snowflake (cloud data warehousing)
Microsoft Fabric (lakehouse architecture)
Programming & Automation
Technical skills that power custom RBQM solutions and integrations
R
12+ years, primary programming language
Shiny application development
Statistical analysis and modeling
Data manipulation (dplyr, tidyr, data.table)
API integration (httr, jsonlite)
Report automation (R Markdown, officer)
Python
10+ years
Web application development (Streamlit, Dash, Flask)
Data science (pandas, numpy, scikit-learn)
API development (FastAPI, Flask)
Automation scripting
Database connectivity (SQLAlchemy, psycopg2)
SQL
15+ years across PostgreSQL, SQL Server, MySQL, Oracle
Complex query optimization
Stored procedure development
Data warehouse design
ETL pipeline development
Performance tuning
Git / Version Control
10+ years
GitHub, GitLab, Bitbucket
Branching strategies for team collaboration
CI/CD pipeline integration
Code review processes
Documentation and change management
Validation & Compliance
Ensuring RBQM systems meet regulatory requirements
Computer Software Assurance (CSA)
6+ years, 8+ validations completed
Risk-based validation planning
Critical feature identification
Test case development (scripted + exploratory)
Validation documentation (150-200 pages vs. 1,200+ with CSV)
FDA inspection readiness
21 CFR Part 11 Compliance
10+ years
Audit trail implementation
Electronic signature workflows
User access control and role management
Data integrity controls
Compliance documentation
GxP Documentation
12+ years
User Requirements Specifications (URS)
Functional Specifications (FS)
Design Specifications (DS)
Standard Operating Procedures (SOPs)
User manuals and training materials
Why Platform Expertise Matters
Most RBQM consultants know the theory. I know the tools. When you hire me, you're not getting generic advice—you're getting someone who has configured Medidata KRI libraries, built custom R Shiny dashboards, integrated ePRO APIs, and validated platforms for FDA inspections.
This hands-on technical experience means I can:
- Accurately estimate timelines and costs for RBQM implementations
- Identify technical roadblocks before they derail your project
- Train your team on platform-specific best practices, not generic theory
- Build custom solutions when commercial platforms don't fit your needs
- Speak the same language as your IT and data engineering teams
Not Sure Which Platform Is Right for Your Trials?
Read my vendor-neutral guide to selecting RBQM platforms based on your specific needs.
Need Help with Your RBQM Platform?
Whether you need platform enablement, custom dashboard development, or technical training, I can help you get more value from your RBQM technology investment.