Validated Core

The Validated Core offers a comprehensive 21 CFR Part 11 compliant system designed to manage and document imaging workflows from ingestion to insight. This software ensures enhanced visibility into imaging data, promoting efficient and error-minimized processes for regulatory submissions.

By enabling the full documentation of workflows and managing fully-provenanced data and imaging endpoints, it facilitates the submission of data packages to regulatory bodies. Features include controlled access and editing rights, operational system checks, exportable time-stamped audit trails, and secure data access across locations, which accelerates academic-industrial collaboration.

Develop Production-Ready AI

Use this system to automate the curation and processing of imaging data, saving time and effort. Run and document defined imaging workflows, track changes to datasets with timestamps and signatures, and log model version developments and parameters.

Deployment and Services

The software is deployable in your preferred cloud environment, offering a secure setting for compliant research. Managed audit services provide access to compliance documentation and data management policies, streamlining submission processes. Custom workflow support is available to ensure seamless execution of standard operating procedures, alongside professional services for consultations and specific development needs.

Application in Clinical Trials

The Validated Core is instrumental in central imaging reviews, exemplified by its use in a Phase 3 clinical trial for assessing a diabetic retinopathy treatment. It enables centralized data uploads from dispersed clinical sites, with audit trails ensuring FDA-compliant traceability of any data changes.

Achieving compliance and 21 CFR Part 11 data integrity through this validated platform allows for proper data storage and reuse, expediting the creation of new treatments.