TRE

Lifebit's Trusted Research Environment (TRE) is a federated, secure digital platform purpose-built for life sciences and biomedical research. Designed for public sector bodies, federal health agencies, pharmaceutical and biotech companies, data providers, and health nonprofits, it enables approved researchers to access, analyse, and derive insights from sensitive health data without ever moving or duplicating that data. As the pioneer of the federated TRE — also known as a Data Safe Haven or Secure Data Environment — Lifebit combines uncompromising security with practical usability, supporting collaborative research at scale across distributed datasets covering more than 250 million patients.

Unlike traditional approaches that anonymise and transfer patient data to a central computing location, Lifebit's TRE brings analysis and computation directly to where biomedical data resides. This federated-by-design architecture keeps data within the organisation's own cloud environment and jurisdictional boundaries, eliminating re-identification risk, reducing data transfer costs, and ensuring full compliance with data residency and privacy regulations.

Core Platform Capabilities

• Federated architecture: Data and computation remain within the organisation's own infrastructure, meaning patient-level data never moves and is never exposed to shared environments.
• Fast data harmonisation and product creation: Lifebit enables the creation of fit-for-purpose data products at scale, trusted by top pharma companies and data providers.
• Joint queries across distributed databases: The platform supports federated queries across fragmented, unstructured biomedical datasets, enabling collaborative research without unnecessary barriers.
• Cohort building in 30 seconds: Researchers can rapidly identify data and create patient cohorts directly within the secure workspace.
• FAIR analysis: The platform supports Findable, Accessible, Interoperable, and Reusable (FAIR) analysis workflows to produce reliable, reproducible results.
• Role-based access control: Customisable settings and role-based permissions ensure every team member has the right level of access and resources.
• Integrated communication and collaboration tools: The TRE is designed for seamless team collaboration with self-service capabilities and scalable solutions.
• Export approval workflow: Users can export analysis results while administrators review and approve export requests, keeping sensitive underlying data secure at all times.

How the TRE Workflow Operates

1. Create Workspaces and invite users: Data administrators can set up and manage Organisations and Workspaces in under 10 minutes, with automatic connection to the organisation's cloud and network using top-tier security configurations.
2. Enable approved data in the Workspace: Administrators control which datasets are made available within each Workspace, ensuring only authorised data is accessible.
3. Access Workspace and create cohorts: Researchers log in to their secure Workspace and can build patient cohorts in as little as 30 seconds.
4. Perform FAIR analysis to get results: Approved users run analyses, deploy pipelines, and apply AI models directly within the secure environment.
5. Export results with admin approval: Researchers submit export requests for analysis outputs, which administrators review before release, maintaining data security throughout.

Security and Compliance

• End-to-end data governance and security by design, based on an advanced federated architecture.
• Adherence to the Five Safes Framework to ensure strict data residency and secure access.
• Compliance with global security standards including FedRAMP, GDPR, HIPAA, ISO, and SOC II.
• Data remains 100% within the organisation's own environment, eliminating exposure to shared infrastructure.
• Pseudonymisation and strict access controls protect patient privacy throughout the research lifecycle.

Use Cases Across Segments

• Public Sector Initiatives: Controlled data access and sharing, population genomics research, cohort building and analysis, and data commercialisation.
• Federal Health: Secure analysis of sensitive data, controlled data access and sharing, and internal R&D.
• Data Providers: Secure and controlled management of clinico-genomic and real-world data, including data commercialisation.
• Health Nonprofits: Storage, computing, multi-omics data analysis, population genomics research, and data commercialisation.
• Pharma and Biotech: Multi-modal and multi-omics data analysis, NGS data processing, target identification and discovery, and patient subtyping and stratification.

Demonstrated Impact

• 5× faster than competing solutions for identifying data, creating cohorts, deploying pipelines and AI models, and performing analyses.
• 100% results guarantee: Lifebit is the only TRE to contractually guarantee that clients achieve results, backed by a platform proven to handle datasets from over 250 million patients.
• 100% data residency: Data stays within the client's own environment, ensuring security compliance and reducing organisational risk.

Lifebit's TRE is deployable as a Federation Platform-as-a-Service (FedPaaS), keeping data and computation within the organisation's own cloud account. This model eliminates egress fees, avoids costly data migrations, optimises cloud costs by leveraging the organisation's own provider discounts, and ensures ongoing compliance with data residency regulations. It is the most widely adopted TRE on the market and is trusted by the world's leading biomedical organisations.