CRE

CRE is a multi-tenant, validated Statistical Computing Environment (SCE) designed specifically for compliant clinical data analysis. It harnesses the full potential of R, RShiny, and the RStudio IDE within a secure, audit-ready framework that adheres to 21 CFR Part 11 and GxP standards. This environment is built to prioritize security, collaboration, and reproducibility, enabling teams to develop, deploy, and maintain RShiny applications alongside validated R analyses within a trusted setting for regulated studies.

The platform unifies R, RShiny, and the RStudio IDE into a single, compliant workspace tailored for clinical research. All analyses and assets are managed under validated controls, allowing the freedom of open-source innovation within a secure, GxP-compliant infrastructure.

CRE facilitates the transformation of validated insights into interactive RShiny dashboards and visualizations within the same compliant environment. Each deployment adheres to controlled validation and access procedures, ensuring that every output is traceable, auditable, and ready for submission.

Consistency and reproducibility are key features of CRE, providing a validated foundation for reproducible results through consistent package versions and controlled environments. This approach minimizes revalidation efforts, enhances traceability, and supports compliant, data-driven decision-making.

Key Features

• Clinical Purpose: Designed to meet the rigorous demands of clinical research, ensuring every R, RShiny, and RStudio workflow is version-controlled, validated, and compliant for submission.
• Controlled Configuration: Allows users to define and maintain their own validated package repositories and environment standards, ensuring consistency, efficiency, and compliance across studies.
• Centralized Workspace: Brings the entire study team together in one secure, validated environment where RShiny and RStudio operate side by side for seamless collaboration and review.
• Contained Infrastructure: Protects sensitive data within a secure, isolated environment that mitigates open-system risk while maintaining the flexibility of open-source analytics.
• Compliance: Guarantees that every workflow meets global regulatory standards with built-in compliance, full traceability, and audit-ready assurance.
• Credible Innovation: Combines open-source flexibility with regulated precision, enabling confident innovation without compromising compliance.

CRE offers flexible deployment models to suit organizational infrastructure and compliance frameworks. The Subscription Model provides access to a fully validated SCE hosted and managed by CIMS within a secure, GxP-compliant infrastructure, eliminating the complexities of setup, maintenance, and validation. Alternatively, the Enterprise Deployment model allows for internal hosting within an organization's validated environment under existing security and compliance controls. Both models ensure a validated experience, supporting compliant, reproducible workflows for regulated clinical research.