A New Approach to ECG Management in Clinical Trials

A portfolio of new software solutions offers a new approach to cardiac safety in clinical trials, overcoming many of the perceived barriers to centralizing all electrocardiograms (ECGs).

The Centralized Cardiac Safety 2.0 suite utilizes a newly developed software technology, which improves data quality, reduces the investigator workload, and improves the overall user experience at the investigative site. These developments enable the collection of real time, consistent, and quality information, easing site operations for all participants and delivering better value to biopharmaceutical companies. The commercial value to sponsors and contract research organizations is derived principally from significant cost savings and operations more efficient across entire programs of drug development, regardless of therapeutic area.

Innovative new instruments that can be integrated with the software platform, such as the Mortara Instrument (Milwaukee, WI, USA) ELI-PC are designed to reduce substantially ECG equipment and systems interface costs associated with a centralized approach system by interacting automatically with the central database, reducing both site workload and the volume of queries generated, and accelerating trial timelines. The integration of the new ECG device into computer systems will also enable key information (such as patient demographics) to be automatically downloaded before a trial, saving staff time and costs associated with trial set-up. Utilization of the new technology with the process enhancements and the reduced site and sponsor burden is intended to deliver significant and measurable cost savings, as well as faster database lock times. The Centralized Cardiac Safety 2.0 suite is a development of ERT (eResearchTechnology, Philadelphia, PA, USA).

"This new approach focusing on people, process, and technology will make it easier for companies to adopt a centralized solution as it promises to deliver better science, lower sponsor costs, and more convenience for all stakeholders,” said Michael McKelvey, president and CEO of ERT. "The combination of better software processes and this revolutionary new ELI-PC device makes it easier and less costly for trial sponsors to adopt an efficient, high quality, centralized model.”

The ELectrocardiograph with Intelligence (ELI) PC device joins the Mortara series of electrocardiographs which offer a broad range of solutions for diagnostic ECG acquisition utilizing a proprietary interpretation algorithm called Veritas. The product line includes a range of models, from high-volume systems to compact hand-held devices, all with a full range of bidirectional connectivity options.

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