ERT Launches “Centralized Cardiac Safety 2.0”: A Revolutionary New Approach to ECG Management in Clinical Trials
Product News Mar 12, 2010
These new solutions overcome many of the perceived barriers to centralizing all ECGs in clinical trials. ERT’s aim is to improve the science of cardiac safety while helping sponsors reduce overall costs with the adoption of a fully centralized approach.
ERT is an established leader in centralized ECG core lab services. ERT’s Centralized Cardiac Safety 2.0 utilizes newly developed software technology, within its best in class EXPERT operating platform, which improves data quality, reduces the investigator workload and improves the overall user experience at the investigative site. This technology enables the collection of real time, consistent, quality information easing site operations for all stakeholders and delivering better value to biopharmaceutical companies. The commercial value to sponsors and contract research organizations is derived principally from significant cost savings and more efficient operations across entire programs of drug development regardless of therapeutic area.
To further enable trial sponsors to take full advantage of the benefits offered by this centralized ECG model, innovative new instruments are necessary to provide improved accuracy, reliability, space efficiency and cost effectiveness. As part of our Centralized Cardiac Safety 2.0 solution, ERT has also introduced ELI-PC under exclusive license from Mortara Instrument. This will substantially reduce the ECG equipment and systems interface costs associated with a centralized approach. This small hand-held ECG collection device will make it easier for companies to adopt a centralized system as it interacts seamlessly and automatically with the central database, dramatically reducing both site workload and the volume of queries generated. This reduction in queries will accelerate trial timelines in the same way that EDC has improved the data collection process in clinical trials in recent years.
Integration of this new ECG machine into computer systems will 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 this new technology incorporated with the process enhancements and reduced site and sponsor burden will result in significant and measurable cost savings as well as faster database lock times.
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. Dr. Michael McKelvey, President and CEO of ERT, comments, “We are extremely pleased to announce ERT’s new Centralized Cardiac Safety 2.0 offering, which represents an innovative new approach for cardiac safety in clinical trials. 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.”