Whatever the context or the study design, Biotrial’s Core Lab can set up adapted solutions for cardiac safety monitoring. We provide digital ECG (Electrocardiogram) or ABPM (Ambulatory Blood Pressure Monitoring) devices, train users, and ensure support throughout the study to guarantee high-quality recordings.
Services dedicated to cardiology also include the central reading of cardiac MRI, Cardiac Ultrasound, or Scintigraphy.
Biotrial’s central cardiac safety services are tailored to complement the site’s medical expertise and provide a central cardiologist review of cardiology exams. Our pool of cardiologists includes experts in ECG, Trans-Thoracic Ultrasound (TTUS) and cardiac ultrasound.
Biotrial offers a complete ECG expertise adapted to sponsor requirements and backed by our quality control, our validated tools, our methods and our qualified cardiologists.
Our cardiologists are specifically trained in ECG manual reading – perform reliable ECG reviews, providing individual reports for participant follow-up.
Qualitative Assessment
The qualitative analysis consists of establishing a diagnosis, by describing any abnormalities observed on the electrocardiographic waveform:
Study sites receive an ECG report informing them of the results of the central cardiologist read and allowing them to implement any actions as needed.
Ambulatory Blood Pressure Monitoring is a key component to several trials to monitor participant variation in blood pressure levels. This can be a safety marker in case of a suspected adverse effect or an efficacy marker, e.g. for blood pressure control medications.
Biotrial provides sites with devices for Blood Pressure measurement, adapted to project needs:
Our Signal processing group extracts the Blood pressure data for regular review and analysis.
A key aspect of Cardiac Safety or efficacy endpoint evaluations can be imaging results.
Biotrial’s Core Lab has expertise in supporting sites for central analysis of Cardiac MRI as well as Cardiac MRI (TTUS).
Our pool of cardiologists includes members who routinely review these recordings in their clinical practice as well as for Biotrial clinical studies.
The central review complements site capabilities and provides a homogenous reading for multi-site trials.
Multi-reader organizations with endpoint adjudication can be set up for these readings.
Biotrial Phase I Clinics
External CPU & Hospitals
Main sponsor contact throughout the trial. Organizes all aspects of the project at Biotrial.
In charge of technical elements: device selection and setup, user manual, central reading manual.
Selected from the pool of experts depending on exam to be read: cardiologists, radiologists, with various expertise
Collects endpoints into the agreed DB format, transfers this to sponsor at agreed timepoints
