Lifebit R.E.A.L.

Lifebit R.E.A.L. is an AI-powered, real-time adverse drug reaction (ADR) surveillance platform designed for regulatory bodies, public health agencies, and pharmaceutical organisations. By continuously analysing global real-world data—spanning structured clinical records and unstructured sources—it delivers immediate pharmacovigilance insights, eliminating the delays associated with manual review and enabling proactive patient safety management.

Trusted by leading institutions including the NIH, Singapore's Ministry of Health, and Boehringer Ingelheim, Lifebit R.E.A.L. sets a new standard for scalable, compliant ADR monitoring. The platform is built to reduce surveillance costs by up to 30%, detect new adverse events in under 24 hours, and provide 100% traceability across all case clustering, signal evaluation, and reporting workflows.

Core Capabilities

• AI-powered signal detection at scale: Automatically detects emerging ADRs in real time using AI-driven analysis of both structured and unstructured global data, minimising manual review delays.
• Broad data source coverage: Continuously scans electronic health records (EHRs), safety databases, spontaneous reporting systems, clinical notes, public health records, scientific literature, and social media for emerging safety signals.
• Geographic and demographic signal tracking: Interactive dashboards display geographic case maps, spike alerts, and granular case-level data with filters by drug, demographic, region, and clinical outcome.
• AI-driven signal prioritisation: AI models rank detected signals by severity, frequency, and novelty, enabling teams to focus on the most critical risks and drill into supporting evidence and affected populations.
• Regulatory-grade reporting: Export datasets, download trend visualisations, and generate summary PDFs backed by full data lineage and audit trails to support regulatory reporting and internal reviews.
• Federated compute and cost governance: Leverages federated AI and cloud resource optimisation to deliver intelligent cost governance, achieving up to 30% savings in surveillance costs.

How Lifebit R.E.A.L. Works

1. Access and configure: Log in to the platform and specify the drug(s), therapeutic class, population, or event type to monitor. The system instantly configures real-time surveillance parameters with no code or setup required.
2. Monitor emerging risks: The platform continuously scans global data sources—including clinical notes, public health records, and spontaneous reporting systems—to surface real-time ADRs across populations and geographies.
3. Detect and visualise ADR signals: Interactive dashboards present geographic case maps, spike alerts, and case-level data, enabling instant signal tracking, risk assessment, and proactive action planning.
4. Prioritise and triage: AI models evaluate and rank signals by severity, frequency, and novelty, providing timelines and supporting evidence to accelerate decision-making.
5. Generate and share reports: Export findings as datasets, trend visualisations, or summary PDFs, with full audit trails supporting both regulatory submissions and internal safety reviews.

Key Benefits

• Eliminate manual review processes and reduce associated operational costs
• Safeguard patients through continuous, automated ADR monitoring
• Accelerate post-market safety monitoring and signal detection
• Maintain compliant reproducibility with 100% traceability across all workflows
• Prioritise security across health and research data ecosystems

Lifebit R.E.A.L. is fully compliant with FedRAMP, HIPAA, GDPR, and FDA guidelines, making it suitable for deployment across regulated public health and pharmaceutical environments. Enterprise customers benefit from premium onboarding, workspace setup, enterprise-grade access control, configurable role-based approval policies, and 24/7 compliance and platform support. The platform also integrates within the broader Lifebit product suite, which includes a Trusted Research Environment, Trusted Data Lakehouse, Trusted Data Factory, and TargetID, enabling organisations to unify their data strategy end to end.