ERT, a provider of centralized services to the biopharmaceutical, medical device and related industries, has launched Centralized Cardiac Safety 2.0, a portfolio of new solutions that enable a new approach to cardiac safety in clinical trials.
ERT’s Centralized Cardiac Safety 2.0 utilises newly developed software technology, within its expert operating platform, which improves data quality, reduces the investigator workload and improves the overall user experience at the investigative site.
As part of our Centralized Cardiac Safety 2.0 solution, ERT has also introduced ELI-PC under exclusive license from Mortara Instrument. This will reduce the ECG equipment and systems interface costs associated with a centralized approach.
The 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. The 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. Utilisation of this new technology incorporated with the process enhancements and reduced site and sponsor burden will result in measurable cost savings as well as faster database lock times.
Michael McKelvey, president and CEO of ERT, said: “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.”
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.