CRE

CRE (Compliant R Environment) by CIMS Global is a multi-tenant, validated Statistical Computing Environment (SCE) purpose-built for compliant clinical data analysis. It brings together the full capabilities of R, RShiny, and the RStudio IDE within a secure, audit-ready framework that meets 21 CFR Part 11 and GxP regulatory standards. CRE is designed for clinical research teams that need the flexibility of open-source innovation without the risks associated with open systems.

By uniting R, RShiny, and the RStudio IDE in a single compliant workspace, CRE empowers teams to build, deploy, and maintain RShiny applications alongside validated R analyses within one trusted environment for regulated studies. Every analysis and asset operates under validated controls, enabling secure collaboration, reproducibility, and submission-ready outputs.

Core Capabilities

• Unified compliant workspace: Combines R, RShiny, and the RStudio IDE in a single, GxP-compliant infrastructure, allowing the full study team to collaborate and review within one secure, validated environment.
• Interactive RShiny analytics: Transforms validated insights into interactive RShiny dashboards and visualizations within the same compliant environment, with each deployment following controlled validation and access procedures to ensure every output is traceable, auditable, and submission-ready.
• Consistency and reproducibility: Delivers a validated foundation for reproducible results through consistent package versions and controlled environments, reducing revalidation effort, strengthening traceability, and supporting compliant, data-driven decision-making.
• Version-controlled workflows: Ensures every R, RShiny, and RStudio workflow is version-controlled, validated, and compliant for regulatory submission.
• Controlled configuration: Empowers customers to define and maintain their own validated package repositories and environment standards, ensuring consistency, efficiency, and compliance across every study.
• Contained infrastructure: Safeguards sensitive data within a secure, isolated environment that removes open-system risk while preserving the flexibility of open-source analytics.

Key Features

• Clinical Purpose: Designed specifically for the rigor of clinical research, with every workflow built to meet the demands of regulated submissions.
• 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.
• Compliance: Ensures every workflow meets global regulatory standards with built-in compliance, full traceability, and audit-ready confidence.
• Credible Innovation: Combines open-source flexibility with regulated precision, enabling clinical data science teams to innovate confidently without compromising compliance.

Flexible Deployment Models

• Subscription Model: Access CRE as a fully validated 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 an existing validated environment under the organization's own security and compliance controls.

Both deployment models deliver the same validated experience, ensuring compliant and reproducible workflows for regulated clinical research. CRE is supported by a dedicated whitepaper and is available for demonstration, making it a comprehensive solution for life sciences organizations seeking to modernize their statistical computing infrastructure while maintaining full regulatory compliance.