Ensuring the highest levels of safety and accuracy in your clinical trials
Cardiac safety is a key component of any drug or device clinical trial, with regulatory authorities requiring sponsors to demonstrate cardiac safety for all drugs. The collection and reporting of high-quality data is therefore essential to drive decisions across all phases of drug development.
We can help to assure the safety of all your clinical trial participants with our end-to-end cardiac safety monitoring services, including electrocardiography (ECG), event monitoring, blood pressure monitoring (BPM), long-term Holter monitoring, echocardiography (ECHO) and multi-gated acquisition scan (MUGA) studies.
Additionally, we can provide a range of cardiac monitoring devices, including both site-based equipment and patient centric, at-home devices for decentralised approaches to cardiac safety monitoring in clinical trials.
ICON supports all major cardiovascular testing modalities and use state-of-the-art technology to collect and transfer data efficiently and accurately, delivering high-quality results you can trust. Our broad team of over 120 medical professionals including medical doctors, cardiovascular research scientists, cardiac experts, cardiovascular electrophysiologists, TTM/Holter technicians, KOL expert consultants and board-certified cardiologists supports every aspect of your trial – from protocol design, statistical analysis, CSVR writing, expert report writing and communication with regulatory agencies.
We support cardiac safety monitoring by offering a full range of ECG reading methodologies.
Our blood pressure data upload system offers instant feedback to site personnel, even before data is transferred, enabling staff to make key decisions or perform additional procedures if needed. Once centralised, data is processed into analysable sets, including requested systolic BP, diastolic BP, heart rate, mean arterial pressure, pulse pressure and rate pressure.
A variety of event monitors can be used for all phases of clinical drug development and device studies. Drug development studies, such as those for atrial fibrillation, are typically designed for patients to call in daily and in case of a dysrhythmia event.
Holter recordings, that can range from 24 to 48 to 72 hours and up to 7 days, are analysed by cardiovascular medical doctors, then reviewed and authorised by a board-certified cardiologist or electrophysiologist, if required.
Experienced physicians perform all ECHO analyses, including quantification of cardiac chamber size, ventricular mass, cardiac function, volume and wall thickness.