Revolutionary New Approach to ECG Management in Clinical Trials

ERT announced the launch of Centralised Cardiac Safety 2.0, a portfolio of new solutions that enable a significant new approach to cardiac safety in clinical trials. These new solutions overcome many of the

perceived barriers to centralising 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 centralised approach.

ERT’s Centralised Cardiac Safety 2.0 utilises 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.

To further enable trial sponsors to take full advantage of the benefits offered by this centralised ECG model, innovative new instruments are necessary to provide improved accuracy, reliability, space efficiency and cost

effectiveness. As part of the Centralised 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 centralised approach. This small hand-held ECG collection device will make it easier for companies to adopt a centralised 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.