CRE: The Compliant R Environment
Open-source power without open-system risk.
CRE is a multi-tenant, validated Statistical Computing Environment (SCE) designed for compliant clinical data analysis. It leverages the full capabilities of R, RShiny, and the RStudio IDE within a secure, audit-ready framework that meets 21 CFR Part 11 and GxP standards. Built for security, collaboration, and reproducibility, CRE empowers teams to build, deploy, and maintain RShiny applications alongside validated R analyses within one trusted environment for regulated studies.
Unifying validated R and RShiny tools in one secure environment
Unites R, RShiny, and the RStudio IDE in a single, compliant workspace built for clinical research. All analyses and assets operate under validated controls, providing the freedom of open-source innovation within a secure, GxP-compliant infrastructure.
Delivering interactive analytics through compliant RShiny applications
Transforms validated insights into interactive RShiny dashboards and visualizations within the same compliant environment. Each deployment follows controlled validation and access procedures, ensuring every output is traceable, auditable, and submission-ready.
Ensuring consistency and reproducibility
Delivers a validated foundation for reproducible results through consistent package versions and controlled environments. This consistency reduces revalidation effort, strengthens traceability, and supports compliant, data-driven decision-making.
Key Features
Clinical Purpose
Designed for the rigor of clinical research, ensuring every R, RShiny, and RStudio workflow is version-controlled, validated, and compliant for submission.
Controlled Configuration
Empowers customers to define and maintain their own validated package repositories and environment standards. This control ensures consistency, efficiency, and compliance across every study.
Centralized Workspace
Unites the full study team in one secure, validated environment where RShiny and RStudio run side by side for seamless collaboration and review.
Contained Infrastructure
Safeguards sensitive data within a secure, isolated environment that removes open-system risk while preserving the flexibility of open-source analytics.
Compliance
Ensures every workflow meets global regulatory standards with built-in compliance, full traceability, and audit-ready confidence.
Credible Innovation
Transforms how clinical data science teams work by combining open-source flexibility with regulated precision. Enables confident innovation without compromising compliance.
CRE Whitepaper
Flexible Deployment Models
CRE adapts to your organization’s infrastructure and compliance framework through two validated deployment options.
Subscription Model
Access CRE, a fully validated Statistical Computing Environment (SCE), hosted and managed by CIMS in a secure, GxP-compliant infrastructure. This model removes the complexity of setup, maintenance, and validation, allowing teams to focus on analysis and innovation rather than system management.
Enterprise Deployment
For organizations that require internal hosting, CRE can be implemented within your validated environment under your existing security and compliance controls.
Both models deliver the same validated experience, ensuring compliant, reproducible workflows for regulated clinical research.
