Unlock your clinical trial imaging data with Flywheel Validated, an end-to-end 21 CFR Part 11 compliant platform. Get actionable insights and greater visibility for trial stakeholders.
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Flywheel Validated expands on the capabilities of the Flywheel medical imaging data management platform, offering validated imaging data management and analysis, plus advanced support for multicenter studies, imaging reads and quality control.
Flywheel can be deployed in three different configurations, depending on your research and compliance needs. Flywheel Validated gives you full 21 CFR Part 11 compliance, with project locking and e-signatures, plus biannual support hours with a customer-hired auditor.
Ensure a secure environment that can be used for compliant research.
Flywheel Validated includes 21 CFR Part 11 compliance support such as documentation and data management policies.
Define the day-to-day support and workflow migration you need to seamlessly execute standard operating procedures.
Get access to experienced data scientists who can consult with you and develop custom Flywheel Gears, containerized algorithms that automate routine tasks.
A research laboratory needed a way to conduct a complex Phase 3 clinical trial to assess the efficacy of a new treatment in participants with diabetic retinopathy. With Flywheel Validated, researchers in dispersed clinical sites are uploading ophthalmic images and data from multiple sites into one, centralized location for comprehensive reader review. Everything done in the trial is completed with audit trails to achieve FDA compliance and ensure any changes to the data are traceable.
With greater data access, built-in compliance options and human-in-the-loop reader workflows, Flywheel gives you more control — for faster go-to-market and data use beyond the trial.
