ERT has announced the launch of its Centralized Cardiac Safety 2.0 portfolio of solutions to enable a new approach to cardiac safety in clinical trials.
These solutions are designed to 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.
Centralized Cardiac Safety 2.0 utilises new software technology, within ERT's Expert operating platform, to improve data quality, reduce the investigator workload and improve the overall user experience at the investigative site.
This technology enables the collection of real-time, consistent information easing site operations for all stakeholders.
The commercial value to sponsors and contract research organisations is derived principally from cost savings and more efficient operations across entire programmes of drug development regardless of therapeutic area.
To further enable trial sponsors to take full advantage of this centralised ECG model, new instruments are necessary to provide improved accuracy and reliability.
As part of the Centralized Cardiac Safety 2.0 solution, ERT has also introduced ELI-PC under license from Mortara Instrument.
This will reduce the ECG equipment and systems interface costs associated with a centralised approach.
This hand-held ECG collection device interacts automatically with the central database, which reduces both site workload and the volume of queries generated.
Integration of this ECG machine into computer systems will enable key information, such as patient demographics, to be automatically downloaded before a trial.
