How Visby Achieved De Novo Marketing Authorization with Medrio CDMS/EDC

Visby Medical, an emerging diagnostics company, developed the first PCR test for STI detection in an at-home setting. To achieve first-to-market status, they needed to run a fast-paced pivotal study with a data management partner they could trust.

With Medrio CDMS/EDC, Visby’s team gained the intuitive data capture, powerful reporting, and rapid support they needed to achieve FDA Do Novo marketing authorization.

In this case study, see how Visby Medical utilized Medrio CDMS/EDC to:

Build and deploy a study in less than one month
Collect comprehensive study data with real-time image uploads
Reduce CRA resources by 66%
Submit to the FDA 45 days after the last participant visit

Contributing experts from Visby Medical:
Sradha Prabhulkar, Manager of Clinical Affairs

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