The cardiovascular safety profile of novel therapeutics is paramount for their success and approval by regulatory bodies. Therefore, meticulous assessment of cardiological parameters is a fundamental aspect of clinical trials.
The acquisition and analysis of cardiac assessment and safety data are indispensable during the planning and execution of clinical trials. Careful monitoring of cardiac activity is essential to ascertain the safety of all study participants. The gathered data is subsequently incorporated into a drug safety data package submitted to the regulatory authorities.
The cardiovascular safety profiles of novel therapeutic substances is paramount for their success and approval by regulatory bodies. Therefore, the careful assessment of cardiac parameters is a vital element of clinical trials.
Cardiac assessment and safety is essential at the stage of planning and conducting clinical trials, and therefore cardiac activity is precisely monitored to ensure the safety of all study participants. The collection and analysis of data from the trial is subsequently incorporated into a drug safety data package submitted to the regulatory authorities
We prioritize the safety of our healthy volunteers and patients. Our objective is to conduct clinical trials that adhere to leading industry standards, and strive to generate high-quality clinical data, while ensuring the well-being of our volunteers and patients. In pursuit of this objective, we employ an advanced portable wireless telemetry system, capable of capturing high-quality data, identifying cardiac events, and detecting anomalies in cardiac conduction and rhythm, thereby minimizing health risks to our subjects. This system facilitates continuous on-screen observation of large cohorts of study participants and is equipped with medical algorithms that trigger alerts based on real-time data analysis.
The ECG recordings are continuously relayed to the medical team for real-time analysis, and daily reports are prepared to maintain a complete overview of the subjects’ safety. Our team of cardiologists can access and display any healthy volunteer or patient’s telemetry data in real-time and will receive notifications via an app or through the web in case of any alarms generated by the subject or analysis algorithms.
Thanks to this innovative solution subjects remain under the direct supervision of medical personnel throughout the clinical trial. This vigilance not only minimizers the risk of adverse events but also ensures that the safety profile of the novel therapeutic is comprehensively established. Through our rigorous cardiac safety protocols, we endeavor to provide a robust foundation for the successful approval and subsequent market introduction of your therapeutic substance.
