VCGen Portal - Virtual Control Group Generation & Analysis

Generate & Analyze Virtual Control Groups

A user-centric platform for guided VCG generation and exploratory database analytics

Powered by VICT3R Database | Integrated with Grit42 API

✓ VICT3R Connected ✓ All Systems Operational
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1,247

Historical Studies

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125k+

Control Animals

⚙️

850+

Endpoints Harmonized

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13

Integrated Tools

VCG Generation Workflow

Seven interconnected steps from data discovery to regulatory-ready reporting

The platform connects data querying through endpoint review, characteristics assessment, study design planning, matching, sampling, quality control, and statistical analysis. Each step builds on the previous, creating a seamless, auditable workflow from raw data to reproducible reports.

1️⃣ Query Data 2️⃣ Endpoints 3️⃣ Characteristics 4️⃣ Design 5️⃣ Match & Sample 6️⃣ QC 7️⃣ Analyze
1

🔍 Query Data

Module: Data Selection & Pool Creation

Discover and filter historical control data from VICT3R via intuitive Grit42 interface. Build your initial study pool with guided filters.

🎯Study characteristics (species, strain, sex, dose)
📋Endpoint selection & real-time preview
📊Pool size & composition indicators
💾Save & reuse filter configurations
🔐Secure encrypted connection
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2

🧬 Review Endpoints

Module: Endpoint Review Engine

Understand endpoint availability, relationships, and data quality. Visualize co-occurrence networks and correlations.

🕸️Co-occurrence networks with interactive visualization
📊Correlation analysis & redundancy detection
✨Data quality assessment by endpoint
💡ICH/OECD regulatory guidance integration
🎯Auto-generated recommendations
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3

📏 Review Characteristics

Module: Study Characteristics Review Engine

Assess data pool suitability, homogeneity, and identify critical vs. non-critical covariates for your endpoints.

⚖️Stratified summaries by species, strain, sex
🎯Endpoint-specific covariate importance analysis
🔍Critical vs. non-critical covariate designation
📊Pool homogeneity scoring & design alerts
💼Guidance on filtering vs. statistical adjustment
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4

🏗️ Study Design Planning

Module: Study Design Considerations & Guidance

Make informed pre-specified decisions on sample size, covariates, matching strategy, and single vs. multiple VCGs.

✅Interactive design decision checklist
📐Sample size calculator with power sensitivity
🎯Covariate selection advisor
🔧Matching strategy recommendations
📄Auto-generated design review document
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5

⚙️ Matching & Sampling

Module: Matching, Sampling & VCG Generation

Execute matching to create a validated pool, then sample to generate one or multiple VCGs with full reproducibility.

🎯Multiple matching algorithms (NN, PSM, Stratified, CBPS)
📊Real-time balance diagnostics & visualization
🧮Single or multiple VCG generation with seed control
📥SEND-format output for LIMS integration
📝Full metadata tracking & reproducibility
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6

✅ Quality Control

Module: VCG Quality Control & Validation

Comprehensive validation ensuring VCGs are statistically suitable for downstream analysis and regulatory submission.

⚖️Covariate balance assessment (SMD, variance ratios)
📊Effective sample size & matching efficiency
📈Per-VCG & cross-VCG consistency metrics
🟢Universal Quality Scorecard (color-coded)
📋Regulatory readiness checklist
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7

📈 Analysis & Reporting

Module: Study Design Classification & Statistical Analysis

Automatically classify study design (Augmented/Dual/Hybrid/Classical) and route to appropriate statistical templates.

🤖Automatic design classification based on VCG config
📐Design-specific analysis templates (25+)
📊Exploratory & inferential analyses
📄One-click regulatory-ready report export
✅Full reproducibility & method documentation

Exploratory Analytics & Insights: Database-Level Discovery

Advanced multivariate tools for understanding VICT3R populations independently of VCG projects

🔬 Scientific Evidence for Regulatory Confidence

Beyond VCG creation, VCGen includes comprehensive exploratory analytics for studying the VICT3R database itself. Scientists can discover relationships among physiological parameters, establish reference ranges, understand control animal variability, and identify population patterns—essential for building regulatory confidence in VCG validity and adoption.

Why This Matters: These tools generate the scientific evidence needed to convince industrial and regulatory stakeholders that VCGs are valid, reliable, and representative of typical control populations. Interactive multivariate analysis reveals patterns that static reports cannot, enabling deep understanding of control animal biology and data quality.
📊 Multivariate Analysis

Principal Component Analysis (PCA)

Visualize high-dimensional physiological data in 2D/3D space to identify patterns, clusters, and outliers among control animals across studies.

📈Interactive 2D & 3D PCA plots with animal grouping by study/species
⚙️Scree plots & variance explained for component selection
🎯Biplot showing variable loadings & contributions
🔍Outlier detection & interactive drill-down
🧬 Pattern Discovery

Hierarchical Clustering & K-Means

Discover natural groupings of animals based on physiological profiles using clustering algorithms with dendrograms and interactive heatmaps.

🌳Dendrogram visualization with customizable distance metrics
🔥Interactive heatmaps showing clustered endpoints
📊K-means with optimal cluster detection (elbow method)
📋Cluster composition tables & characteristics
🕸️ Network Science

Correlation Networks & Co-occurrence Analysis

Map relationships among physiological parameters as interactive networks; understand which endpoints vary together and why.

🕸️Interactive correlation networks with edge filtering
📐Correlation heatmaps (Pearson, Spearman, Kendall)
🔗Co-occurrence matrices by species, strain, age groups
🎯Identify hub variables & endpoint clusters
📊 Normative Data

Reference Ranges & Distribution Profiling

Establish reference ranges for control animals by species/sex/strain; understand parameter distributions and identify typical vs. atypical values.

📈Percentile plots (5th, 25th, 50th, 75th, 95th)
🔔Distribution shape analysis (normality tests, Q-Q plots)
📊Stratified reference ranges (by species, sex, age)
⚖️Outlier thresholds & contextual interpretation
🧠 Latent Dimensions

Factor Analysis & Dimensionality Reduction

Uncover latent physiological dimensions underlying measured endpoints; reduce data complexity while retaining interpretability.

🎯Exploratory factor analysis with scree plots & loadings
📊t-SNE & UMAP for non-linear dimensionality reduction
🔍Communalities & uniqueness assessment
📋Interpretation guides for latent factors
⏱️ Temporal Patterns

Longitudinal & Time-Series Analysis

Analyze physiological changes over time within studies; identify recovery patterns, circadian effects, and age-related trends in control animals.

📈Longitudinal trajectory plots with confidence bands
🔄Spaghetti plots showing individual animal trajectories
📊Mixed-effect models for within-animal variation
🎯Identify study/strain-specific temporal patterns

Seven Integrated Analytical Engines (VCG Workflow)

Each engine serves a critical step in the VCG generation workflow

The VCGen platform integrates seven specialized analytical engines, each designed to address a distinct step in the VCG generation process. These engines work together seamlessly, with outputs from one feeding into the next, creating a unified, auditable workflow.

🔍 ENGINE 1

Endpoint Review Engine

Understand endpoint availability, relationships, correlations, and data quality at the pooled-data level before VCG generation.

🕸️Co-occurrence networks & correlation analysis
✨Data quality assessment & outlier detection
💡Regulatory recommendations (ICH/OECD)
🎯Evidence-based endpoint suggestions
📏 ENGINE 2

Study Characteristics Review Engine

Assess data pool suitability, homogeneity, and identify which covariates are critical for matching vs. suitable for post-hoc adjustment.

⚖️Covariate availability & importance analysis
🎯Critical vs. non-critical designation
📊Homogeneity scoring & pool quality
⚠️Design heterogeneity flags
🏗️ ENGINE 3

Study Design Considerations Module

Embed study design knowledge into the workflow with interactive checklists, sample size calculators, and design review documents.

✅Interactive design decision checklist
📐Sample size advisor & power analysis
🎯Covariate selection advisor
📄Pre-specified design review document
⚙️ ENGINE 4

Matching & Pool Generation Engine

Create a validated Matched Animal Pool using robust algorithms with real-time diagnostics and reproducible output.

🔧Multiple algorithms (NN, PSM, Stratified, CBPS)
📊Real-time balance diagnostics
📝Detailed matching reports & reproducibility
✅Assumption checks & overlap assessment
🧮 ENGINE 5

Sampling & Grouping Engine

Generate one or multiple VCGs from the matched pool with flexible stratification and sampling options.

🎯Single or multiple VCG generation (k=3-100)
📊Stratified & balanced allocation methods
📝Full seed control for reproducibility
💾Metadata tracking & audit trail
✅ ENGINE 6

VCG Quality Control Engine

Comprehensive validation for single and multiple VCGs, ensuring statistical suitability and regulatory readiness.

⚖️Covariate balance (SMD, variance ratios, KS tests)
📊Effective sample size & matching efficiency
🟢Universal Quality Scorecard (color-coded)
📋Regulatory readiness checklist & export
📈 ENGINE 7

Study Design Classification & Analysis Router

Automatically classify study design and route to appropriate statistical analysis templates.

🤖Auto-classification (Augmented/Dual/Hybrid/Classical)
📐Design-specific analysis templates (25+)
📊Exploratory & inferential analysis workflows
📄Automated regulatory-ready reporting
🔗 Seamless Workflow Integration: Each engine outputs feed into the next step, creating a unified, auditable workflow. Design decisions made in Step 4 automatically inform matching configurations in Step 5, and VCG quality metrics from Step 6 determine analysis routing in Step 7.
🔬 Independent Exploratory Analytics: Six advanced multivariate tools enable scientists to explore the VICT3R database independently of VCG projects. Use PCA, clustering, networks, reference ranges, factor analysis, and time-series tools to understand control animal populations and generate scientific evidence for regulatory submissions.
🧮 Flexible Data Inclusion: The portal supports animals with sparse missing endpoint data. The Characteristics Review engine recommends advanced statistical methods (multiple imputation, maximum likelihood) that properly handle missingness patterns while maintaining statistical validity.
🎯 Critical vs. Non-Critical Covariate Intelligence: For each endpoint of interest, the platform analyzes which covariates are crucial (recommend filtering) versus non-critical (recommend statistical adjustment). This enables efficient data pool optimization while minimizing unnecessary exclusions.
📊 Single vs. Multiple VCG Support: Generate a single VCG for standard applications or multiple VCGs (k=10-100) for robustness, sensitivity analysis, and regulatory confidence. Study design automatically routes to appropriate statistical methods (classical, Bayesian, or meta-analytic).
📋 Regulatory Readiness: Every module includes pre-specified templates, checklists, and quality criteria aligned with regulatory expectations. Export regulatory-ready documentation in one click with full reproducibility tracking.

Platform Pillars: What Makes VCGen Different

01

Dual-Purpose Platform

Both VCG generation workflow AND exploratory database analytics independently in one integrated system.

  • Seven-step VCG workflow
  • Six exploratory analytics tools
  • Seamless data integration
  • Independent analysis options
02

Advanced Multivariate Tools

Professional-grade statistical and machine learning analysis for database-level insights.

  • PCA, factor analysis, clustering
  • Correlation & network analysis
  • Reference range establishment
  • Time-series & longitudinal analysis
03

Guided Workflows

Templated, pre-validated workflows for common VCG use cases. Each step includes decision support.

  • Interactive checklists & decision trees
  • Embedded expert recommendations
  • Context-aware help & examples
  • Pre-specified quality criteria
04

Fully Reproducible

All analyses tracked, documented, and easily exportable with complete methodological transparency.

  • Version control & algorithm versioning
  • Parameter recording & snapshots
  • Reproducible code export (R/Python)
  • Audit trail for all decisions
05

Seamlessly Integrated

Direct connection to VICT3R, LIMS systems, and downstream validation pipelines.

  • Grit42 API for VICT3R access
  • SEND-compliant data export
  • LIMS integration ready
  • RESTful module communication
06

Highly Flexible

Support multiple VCG strategies, matching algorithms, and statistical designs.

  • 4 matching algorithms with configuration
  • Single & multiple VCG options
  • 4 study design types (Augmented/Dual/Hybrid/Classical)
  • 25+ analysis templates
07

Comprehensively Validated

Multi-level quality assessment ensures statistical suitability for all VCG scenarios.

  • 6 balance assessment categories
  • Per-VCG & cross-VCG metrics
  • Universal Quality Scorecard
  • Regulatory readiness checklist
08

Regulatory-Ready

Built with regulatory compliance at every step. Pre-specified templates and quality criteria.

  • Design review documents
  • Quality diagnostics reports
  • Regulatory checklists
  • SEND format compliance

Getting Started with VCGen

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User Guides

Complete workflow documentation with screenshots and step-by-step instructions

Start Guides →
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Video Tutorials

5-10 minute videos for each workflow engine, tool, and analysis template

Watch Videos →
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FAQ & Glossary

Common questions, SEND terminology, statistical concepts, and troubleshooting

Learn More →
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Support & Training

Hands-on training sessions, live support, and expert consultations

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Documentation & Resources

📚 User Guides

📊 Statistical Resources

🔧 Technical & Compliance

❓ Help & Learning

Support & Training

📧 Email Support

Get help from our support team

vcgen-support@roche.com

💬 Live Chat

Chat during business hours (Mon-Fri 9-17 CET)

🎓 Training

Hands-on workshops for workflows & exploratory analytics

📞 Priority Support

For urgent issues and technical support

+34 (0) 20 604 0000