CRO device automates cardiac trial monitoring
For cardiac treatment trials, Phase I specialist Spaulding Clinical has developed an automated monitor with biometric verification. The ECG device platform, called Spaulding IQ, has earned FDA 510k approval, the company says.
The device aims to provide drug developers with an automated cardio-data capture tool in a handheld device. Trial subjects use the single-button unit by first speaking into it to provide a voiceprint. The unit then attaches this biometric ID to each ECG recording taken.
Spaulding IQ downloads the ECG data, as well as demographic and visit information, to the Wisconsin CRO's Clinical ECG Information System.
Earlier this month, Spaulding unveiled a biostatistics and data management service for drug developers that want to outsource both clinical trial IT infrastructure and data handling. The service includes database design, data quality specification and testing, Data Query Form generation, integration and verification of external electronic data, and real-time remote data access.