Clinical Trial Linkage

Clinical Trial Linkage is a patient journey software and linked real-world data (RWD) solution from HealthVerity, designed for life sciences organizations seeking to maximize the value of clinical trial investments. It operates as a single-vendor, end-to-end platform that synchronizes patients from clinical trials to their real-world data in a HIPAA-compliant and 21 CFR Part 11-certified environment, powered by HealthVerity Identity Manager.

The solution addresses limitations of legacy tokenization technologies, which contribute to high error rates and restrict access to the full potential of RWD. Clinical Trial Linkage supports patient data access across all stages of clinical research, including retrospective pre-enrollment medical histories, data capture during trials from outside trial sites, long-term follow-up studies, and post-trial surveillance.

Supported Use Cases

• Patient contextualization using real-world data
• Alignment with FDA RWD guidance
• Tracking and recovering patients lost to follow-up
• Post-trial surveillance and monitoring
• Safety studies

Patient Participation Management

• Provides an enterprise-level view of key activities across a single phase II, III, or IV trial or an entire portfolio of clinical trials
• Enables on-demand retrieval of de-identified data for trial patient cohorts, often available the same day
• Maintains full data provenance throughout the process
• Supports tracking and management of patient participation over time

Identity Resolution and Patient Matching

• Built on HealthVerity Identity Manager, which serves as the single source of truth for enrolled patients across the enterprise
• Supports accurate patient matching and identity resolution
• Preserves the option to retrieve de-identified or identifiable patient-centric data on demand

Privacy and Consent Management

• Manages patient cohorts linked to de-identified data throughout the study and beyond
• Certified under 21 CFR Part 11 and compliant with HIPAA requirements
• Provides built-in governance controls for data handling

Real-World Data Discovery and Delivery

• Provides on-demand RWD discovery and delivery from HealthVerity's healthcare and consumer data ecosystem
• Allows trial cohorts to be overlapped in real-time across the RWD universe available in HealthVerity Marketplace
• Supports exploration of comorbidities, biomarkers, and physician notes within a HIPAA-compliant framework
• Enables drag-and-drop data source exploration to examine intersections across datasets

Clinical Trial Linkage integrates with HealthVerity Marketplace for real-time data exploration and cohort building. The platform is designed for enterprise deployment, supporting both individual trial management and portfolio-wide oversight within a governed, compliant infrastructure.