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ECG Safety Reading Team Related information

Cardiac Safety & ECG

At Biotrial, we understand the critical importance of cardiac safety in clinical trials. We offer a comprehensive range of adapted cardiac safety and ECG solutions to help biotechnology and pharmaceutical industry meet their regulatory requirements and ensure the safety of their participants.

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.

Every clinical trial is different, so we tailor our services to meet the specific needs of each study. We work closely with our sponsors to develop a customized plan that will help them achieve their desired results.

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.

ECG Safety Reading

Biotrial’s ECG safety reading services help biotechnology and pharmaceutical industry ensure the safety of their participants in clinical trials. Our services are backed by qualified cardiologists, who are specifically trained in ECG manual reading and provide high-quality, reliable ECG reviews. We offer individual reports for participant follow-up and work closely with our sponsors to develop customized plans that meet their specific needs.

Our ECG safety reading services can help you to:

Identify and assess cardiac safety risks
Monitor participant cardiac health throughout a clinical trial
Comply with regulatory requirements for cardiac safety in clinical trials

Qualitative Cardiologist Review

Biotrial works with cardiologists who provide our sponsors with the highest level of confidence in the quality and accuracy of their ECG data. They are specifically trained in ECG manual reading and interpretation and use their expertise to identify and assess any abnormalities in the electrocardiographic waveform, including:

Rhythm qualification
Morphology and conduction qualification
T wave and U wave qualification

Once the review is complete, study sites receive an ECG report that informs them of the results and provides any necessary recommendations. This allows sites to take prompt action to address any potential cardiac safety concerns.

Central ABPM

Ambulatory blood pressure monitoring (ABPM) is a non-invasive method of recording blood pressure over 24-hours. It is a key component of many clinical trials, as it can be used to monitor patient variation in blood pressure levels and identify potential safety or efficacy concerns.

Biotrial’s central ABPM service helps biotechnology and pharmaceutical industry meet their clinical trial needs. We provide sites with a variety of devices for measurements, adapted to the specific needs of each project.

These devices can be used to collect:

Spot blood pressure measures
Ambulatory Blood Pressure Measures
Home measures

Cardiac Imaging

Cardiac imaging is a key aspect of Cardiovascular safety and efficacy endpoint evaluations. Biotrial’s Core Lab has expertise in supporting sites for central analysis of cardiac MRI and transthoracic ultrasound (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 of cardiac imaging results complements site capabilities and provides a homogenous reading for multi-site trials. Multi-reader organizations with endpoint adjudication can also be set up for these readings.

Benefits of Biotrial’s Central Cardiac Imaging Services

Access to a team of experienced cardiologists with expertise in cardiac imaging
Centralized reading of cardiac imaging results for multi-site trials
Homogenous reading of cardiac imaging results
Multi-reader organizations with endpoint adjudication
Compliance with regulatory requirements for cardiac safety and efficacy endpoint evaluations

Phase I & Multi-centric Trials

Biotrial is a leading provider of Phase I and multi-centric cardiac safety and ECG services. We have a global network of Phase I clinics with highly qualified and experienced clinical staff, a global network of Phase I clinics with 260 fully equipped beds, and fast and efficient recruitment capabilities. We also work with external CPUs and hospitals to provide our clients with the flexibility and scalability they need to conduct their trials.

Biotrial Phase I Clinics

Highly qualified and experienced clinical staff
260 fully equipped beds
Fast & efficient recruitment capabilities

External CPU & Hospitals

Site qualification
Training of local staff
Technical support / Hotline
Feedback with individual reports

TEAM

Project Manager

Main sponsor contact throughout the trial. Organizes all aspects of the project at Biotrial from development to timelines.

Technical Manager

In charge of technical elements: device selection and setup, user manual, central reading manual.

Readers

Selected from the pool of experts depending on the exam to be read: cardiologists, radiologists, with various expertise.

Data Manager

Transfer data to the sponsor at agreed-upon time points, and collect endpoints in the appropriate database format.

Related Information

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