Complex Data Endpoints
Medical device clinical trials require non-standard data types like device usability data that legacy EDC systems weren't designed to capture.
Clinical Evidence, Collected the Modern Way
Medical device clinical trials have unique requirements: device usability data, real-world endpoints, and tight regulatory timelines. Curebase is a real-world evidence platform built to handle all of it.
Challenges
Regulatory Complexity
Navigating FDA and CE mark submission requirements demands audit-ready data from day one on your real-world evidence platform.
Remote Monitoring Gaps
Participants use devices at home, but you're still relying on site visits for device usability data collection in your clinical trial software.
How Curebase Helps
Flexible Data Models
Configure forms and endpoints to match your medical device clinical trial protocol, with no workarounds or custom development needed on our eClinical platform.
Real-World Data Collection
Capture device usability data, patient-reported outcomes, and clinical endpoints from participants wherever they are with our real-world evidence platform.
Submission-Ready Exports
Generate CDISC-compatible datasets and audit trails formatted for FDA and CE mark regulatory submissions from your clinical trial software.
Participant-Centric Design
A mobile experience that keeps participants engaged in medical device clinical trials, reducing dropout and improving data completeness.
See It in Action
Device Usability & Outcomes
Capture patient-reported device usability data alongside clinical outcomes in a single mobile experience, purpose-built for medical device clinical trials.
Frequently Asked Questions
Build Your Clinical Evidence Faster
See how Curebase supports medical device clinical trials from enrollment through submission.