Device Facilitates ECG Collection in Clinical Trials

By HospiMedica International staff writers
Posted on 31 Mar 2011
A portable device with an intuitive, single-button design and a high level of automation aids in centralized electrocardiogram (ECG) collection for pharmaceutical clinical trials.

The Spaulding IQ foolproof ECG device is a handheld device, which reduces errors and allow for data capture in less time and at a lower cost than conventional ECG devices. The Spaulding IQ captures the subject's voiceprint as a means of biometric identification, together with five minutes of ECG recording. Directly after recording, the ECG data, demographic, and visit information are sent to the Spaulding Clinical ECG Information System. The automation and integration requires virtually no involvement from the site personnel.

Image: The Spaulding IQ foolproof ECG device (photo courtesy of Spaulding Clinical Research).

The IQ is a proprietary device of Spaulding Clinical Research (West Bend, WI, USA), which provides onsite and integrated ECG analysis via automatic, semiautomatic, and manual reading options, offering flexibility in securing quality clinical ECG data. Pharmaceutical companies receive near real-time access to their results through an advanced clinical trial management system (ALPHADAS). All lab results are electronic and can be returned within eight hours of collection. Site-to-submission reporting capabilities feature secure online data results for turnkey project management.

"The greatest value of this new process is that it makes it logistically and financially feasible to collect very high-quality, centralized ECG information in virtually all clinical trials,” said Jay Mason, MD, Chief Medical Officer of Spaulding Clinical Research. "This will greatly improve subject safety during trials and drug safety in the marketplace. Pharmaceutical sponsors will gain the ability to make earlier, better-informed drug development decisions.”

Related Links:

Spaulding Clinical Research




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