CLIRINX Clinical Research IT Platform

CLIRINX is a clinical research IT company focused on epilepsy and rare disease research. It provides 21CFR11-compliant, web-based tools for study management, electronic data collection, and participant portals, targeting researchers, patient advocacy groups, and institutions running patient registries, natural history studies, and clinical trial readiness assessments.

The platform supports internet-based research and team science across the full study lifecycle, from design through close-out. CLIRINX works with academic institutions and research groups, with recent deployments including studies at the University of Melbourne and a patient-led registry for Primary Biliary Cholangitis.

Core Modules and Capabilities

• Electronic Data Collection (EDC): Web-based data capture for clinical research studies, with version-controlled case report forms (CRFs) and study documents.
• Patient Portal / Data Sharing: Participant-facing portal enabling data entry and sharing between patients and research teams.
• Medical Imaging Adjudication: Workflow tools to support the review and adjudication of medical imaging data.
• cxText Translation Engine: A translation module to support multilingual research data collection.
• CRID (Clinical Research ID): A system for generating and managing unique participant identifiers across studies; the CRID system has issued nearly 6,000 identifiers to date.
• Data Visualization: Tools to convert collected research data into visual insights.
• Data Sharing: Functionality to unlock and distribute research datasets.
• VarTracker (Genetic Variant Tracking): A module for tracking genetic variants within research studies.
• Big Data: Infrastructure supporting data at terabyte-to-petabyte scale.
• External Database APIs: Integrations with health informatics databases to support data exchange and enrichment.

Registry and Study Support

• Provides IT expertise for patient registries, natural history studies, and clinical trial readiness assessments.
• Guides research teams through IT components from study design to study close-out.
• Supports diverse research endeavors beyond epilepsy, including rare disease registries such as the Rare Disease Data Repository (RDDR) and a Primary Biliary Cholangitis patient-led registry.

Security and Compliance Features

• SSL encryption and encryption of data at rest.
• Unique usernames and passwords, two-factor authentication, and single sign-on via Okta.
• Role-based access control and digital signatures.
• Full audit log and data change history.
• Restricted and encrypted PHI fields.
• Multi-blockchain document timestamps.
• IP and geolocation restrictions, OS-level security, and servers accessible only behind a firewall or SSH with private key encryption.
• Cyber and PI insurance coverage.
• Designed to support HIPAA and 21CFR11 compliance efforts.

CLIRINX operates as a web-based platform and explicitly states that it does not analyze, share, or sell customer data collected through its software. Data ownership remains with the collecting organization. The platform has been used in published research, including a major SCN2A-related publication, and supports ongoing studies at institutions such as the University of Melbourne.