Cardiac Safety Leadership

BioTel Research has been a leader in the cardiac core lab industry since the 1990s. Now, we continue to offer comprehensive, global services, including ECG, event, blood pressure, and Holter monitoring, as well as ECHO and MUGA studies for clinical trials. Part of the world’s largest cardiac data network, we provide all major cardiovascular testing modalities, using state-of-the-art technology to transfer data efficiently and accurately to our secure central data center located near Washington, DC, USA. 

 

 

 

Electrocardiography (ECG)

We offer all ECG reading methodologies that might be requested, using varying degrees of automation and manual application of cardiac expertise. Analyses typically include interval measurements, such as PR, RR, QRS, QT, QTcB and QTcF, QTcI, and other QT correction formulas. It also includes morphological and clinical ECG interpretation provided by a large team of medical doctors and board-certified cardiologists.


 

 

Event Monitoring (CEM, TTM, MCT)

A variety of Event monitors are used for both clinical drug development studies (all phases) and for device studies (primarily post-ablation). Accessing the expertise of our holding company, BioTelemetry, we offer Mobile Cardiac Telemetry (MCT) models and devices. MCT technology provides beat-to-beat, real-time analysis, automatic arrhythmia detection, and wireless ECG transmission. Also, drug development studies (such as those for Atrial Fibrillation) will typically be designed for patients calling in daily, on a pre-agreed schedule, and in case of a dysrhythmia event. These Trans-Telephonic transmissions may be monitored anywhere from 30 days to 6 months. Our team of experienced TTM technicians receive and analyze these transmissions 24/7/365, and address any cardiac issues with the patient by phone.


 

 

Blood Pressure Monitoring (BPM)

Our BP data upload system offers instant feedback to site personnel, even before data is transferred. This immediate analysis enables site staff to make key decisions or perform additional procedures if needed. Once centralized, data is processed into analyzable sets, including requested systolic BP, diastolic BP, heart rate, mean arterial pressure, pulse pressure and rate pressure.


 

 

Holter Monitoring

Holter recordings (24-, 48-, 72-hour, and up to 7 days) are analyzed first by a cardiovascular medical doctor, then reviewed and authorized by a board-certified cardiologist or electrophysiologist, if required. Arrhythmia and Ischemia Reports include rate statistics, tachycardia/bradycardia episodes, supraventricular ectopy, ventricular ectopy, RR variability, ST deviation, pauses, rhythm profile, trends, and waveform examples. For Thorough QT (TQT) studies and other ECG-intensive trials, it is common practice to use Holter devices for continuous data acquisition, extracting 10-second segments for analysis either automatically or manually per Protocol requirements.


 

 

Echocardiography (ECHO) / Multi-Gated Acquisition Scan (MUGA)

BioTel Research, has vast experience in echocardiography (ECHO) and maintains a state-of-the-art ECHO processing infrastructure. Experienced physicians perform all ECHO analyses, including quantification of cardiac chamber size, ventricular mass, cardiac function, volume, and wall thickness. Display modes include 2-D, M-Mode, Doppler, and Tissue Doppler. These procedures are based on the American Society for Echocardiography guidelines, which are widely applied to clinical research and clinical practice.