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Charité VRE Secure Processing Environment

Consulting Virtual
Pricing/Discount Options: Call #2
Unique Identifier: 1385a8b5-1384-49d1-8de7-dac5fa263c26

Service Description

Overview

The Charité Virtual Research Environment (VRE) provides a Secure Processing Environment (SPE) and Trusted Research Environment (TRE) for collaborative processing, exchange, and analysis of human health data in the context of GDPR, AI Act compliance, MDR evidence generation, and Post-Market Clinical Follow-Up (PMCF).

The service enables controlled collaborative processing of sensitive health data within isolated and audit-capable project environments aligned with GDPR and institutional information security requirements. The VRE supports isolated project workspaces on shared multi-tenant infrastructure with secure remote access, managed analysis environments, and traceable processing workflows.

VRE services include:

  • Secure isolated project workspaces
  • Secure data exchange between Charité and external partners
  • Trusted Research Environment / Secure Processing Environment and secure collaboration workflows for sensitive health data like imaging, genetic, or clinical data
  • Remote Desktop virtual machines
  • Managed Jupyter and Linux analysis environments
  • GPU-enabled compute resources
  • Long-term storage, backup, and recovery mechanisms
  • Audit logging and traceability support
  • Monitoring and operational oversight
  • Guacamole/VPN-based remote access
  • Support for automated pseudonymisation and anonymisation workflows
  • SOPs, onboarding, and user support
  • Project coordination and operational support
  • GDPR, MDR, and AI Act support processes
  • Collaborative data analysis and digital evidence generation

How can the VRE help you?

The VRE enables secure and GDPR-compliant collaborative research with sensitive human health data that cannot be fully anonymized, including imaging, genomics, clinical, and other highly sensitive biomedical datasets. The platform provides controlled and traceable access to protected data within isolated project environments designed for secure collaborative processing and analysis.

The VRE supports interdisciplinary collaboration between research institutions, healthcare providers, and industrial partners while reducing the need for uncontrolled data transfers and decentralized data handling. Managed analysis environments, secure remote access mechanisms, audit logging, and controlled collaboration workflows support reproducible and secure data processing in compliance-sensitive research settings.

The VRE can additionally support translational and regulatory-oriented activities such as AI system evaluation, PMCF activities, secure secondary use of health data, federated collaborations, and evidence generation for MDR and AI Act related processes.


How is the VRE accessed?

The VRE is primarily accessed through secure remote access mechanisms. Dedicated isolated project spaces are provisioned on Charité-operated infrastructure. Depending on project scope, the service may range from lightweight onboarding and workspace provisioning to fully managed collaborative environments with operational and compliance support.

Typical project durations range from several weeks to multiple years.


Provider Description

Charité operates advanced research and digital infrastructure environments for secure biomedical and clinical data processing in research and translational medicine contexts. The VRE supports interdisciplinary collaboration between clinical, scientific, and industrial stakeholders in compliance-sensitive environments.


Technical Description

The platform is based on shared multi-tenant infrastructure with isolated project environments. Available resources include virtual machines, GPU-enabled compute nodes, storage systems, managed analysis environments, backup systems, authentication and authorization services, and monitoring capabilities.

The environment supports secure remote access, auditability, traceability, and controlled data exchange workflows for sensitive health data processing.


Service Customization

The service can be customized depending on project requirements, including:

  • Dedicated or shared compute environments
  • GPU-enabled processing
  • Long-term storage requirements
  • Custom virtual machine sizing
  • Federated collaboration scenarios
  • Compliance and documentation support
  • Enhanced operational support models
  • Extended onboarding and training
  • Integration with external infrastructures and workflows
Keywords: MDR VRE Trusted Research Environment TRE Secure Processing Environment SPE PMCF GDPR AI Act secondary use of health data digital evidence generation secure collaborative data processing regulated AI evaluation
Offerings: Data Processing (curation, preprocessing & standardization, mining, visualization, anonymization, FAIR, etc.) Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Software (development, maintenance, deployment, administration, etc.) Platform (trusted research environment, authentication federation, etc.) Infrastructure (compute, storage, network, HPC, etc.)
Provider Logo Service Logo

Provider & Contact

Provider Country Germany
Organisation Website https://vre.charite.de/
Published Email vre-support@charite.de

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs - Research project description and intended data processing activities - Data governance and access requirements - User and collaboration requirements - Datasets or data source specifications - Compute, storage, and analysis requirements - Applicable ethics, GDPR, or institutional approvals where required - Software or workflow requirements for the analysis environment
Service Outputs - Secure isolated project workspace within the Charité VRE - Provisioned remote access and user accounts - Managed analysis environment (e.g. virtual machines, Jupyter, Linux environments) - Secure storage and controlled data exchange mechanisms - Logging, monitoring, and traceability capabilities - Operational onboarding and user support - Documentation and configuration of the provisioned environment - Optional support for pseudonymisation, anonymisation, and collaborative workflows
Dependencies & Restrictions - Availability of infrastructure and operational capacities - Compliance with GDPR, institutional information security, and applicable governance requirements - Clarification of data controller and data processor responsibilities may be required - Additional ethics approvals, data access approvals, or contractual agreements may be necessary depending on the dataset and use case - Use of identifiable or highly sensitive human data may require additional review and governance procedures - Compute, GPU, and storage availability may depend on current platform utilization and project scope - External software deployment may require technical and security review
Certification Support
  • Adherence to clinical and regulatory standards for device testing in healthcare settings
  • GDPR-compliant processing workflows for sensitive human health data
  • Support for MDR and AI Act related evidence-generation activities
  • Support for Post-Market Clinical Follow-Up (PMCF) activities
  • Support for secure secondary use of health data in regulated research contexts
Service Standards
  • BSI IT Grundschutz
  • Europrivacy
  • GDPR
  • ISMS
  • ISO 27001
  • KRITIS