Celerion, a provider of early stage clinical research solutions, has launched a new Hybrid Phase I/ ECG Core lab that provides automated ECG analysis for its global Phase I clinical network.
Celerion said that its automated approach employs technology to perform automated measurement of ECG recordings, thereby minimising cardiologist review and providing clients with faster access to data. The system also effectively identifies the small number of ECG recordings that will still require cardiologist review.
The reduction in cardiologist involvement, combined with much smaller overhead compared to traditional ECG Core labs supporting global clinical trials, allows Celerion to offer significant cost and time savings to clients.
Celerion said that the Hybrid Phase I/ ECG Core lab was developed in collaboration with Analyzing Medical Parameters for Solutions (AMPS), and Global Instrumentation (GI).
Susan Thornton, CEO of Celerion, said: “The introduction of the Hybrid Phase I/ ECG Core lab clearly establishes Celerion as the world leader in innovative early cardiac services. By integrating the ECG functions within our clinic network, minimizing traditional ECG overhead and providing more automation, Celerion enables fast access to data and cost-effective solutions that deliver high-quality data for the execution of thorough QT studies and ECG assessment in SAD and MAD programs.”
Jim DeMaso, president of Global Instrumentation, said: “The GI M12R recorder and M12A Enterprise software provide state-of-the-art Holter functions with full standard 12-lead ECG functionality in a centralized data management system designed for the requirements of clinical trials.
“We are pleased to be part of the Celerion/AMPS collaboration, which has led to the advancement in performing clinical trials using this new semi-automated process.”