Advanced telemetry
in phase 1 trials
The cardiological safety profiles of novel therapeutic substances is paramount for their success and approval by regulatory bodies. Therefore, the careful assessment of cardiological parameters is a vital element of clinical trials.
Cardiac assessment and safety data 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 regulators.
We take patient care very seriously. Our objective is to execute clinical trials that meet leading industry standards, and aim to generate high-quality clinical data, while safeguarding the health of our volunteers and patients. To meet these standards, we monitor our subjects with an advanced portable wireless inpatient telemetry system, which captures high-quality data, any cardiac events, and detects disturbances in cardiac conduction, lowering the risk to health of our subjects. Our system enables the continuous on-screen observation of large cohorts of study participants and is equipped with medical algorithms that generate alarms based on the continuous analysis of actively generated data.
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 patient’s telemetry data in real-time and will receive emergency signals via an app or through the web in case of any alarms generated by the patient or analysis algorithms.
Thanks to this innovative solution patients stay under direct supervision of the medical personnel minimizing the risk for adverse events during your clinical trial while the safety profile of your drug is built comprehensively to the highest standards.