Cardiac Safety

ECG Acquisition

Whatever the context or the study design, Biotrial's ECG Core Lab can set up adapted solutions for ECG collection. We implement our digital ECG system, train users and ensure support during study to guarantee high quality ECG recording.

ECG Devices

Biotrial has broad experience in the use of the following ECG devices:

  • Cardionics Cartouch® for 10-second ECGs
  • Mortara® H12+ for Holter 12-lead ECGs
  • Possibility to work with many other ECG devices

Access to Biotrial Clinics

  • Highly qualified and experienced clinical staff
  • 150 fully-equipped beds
  • Fast and efficient recruitment capabilities

External CPU and Hospitals

  • Site qualification
  • On-site installation by Biotrial ECG technicians
  • Training of local staff
  • Technical support / Hotline

ECG Manual Reading

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.

Quantitative Assessment

Our cardiologists - specifically trained in ECG manual reading - perform reliable measurements of ECG intervals using validated methods and algorithms. Different reading methods are available and selected in collaboration with the sponsor to achieve the most adapted solution.

The overall quality of the QT interval assessment is continuously monitored and Biotrial is able to achieve a very low QTc variability level.

Qualitative Assessment

The qualitative analysis consists in establishing a diagnosis, by describing the abnormalities observed on the electrocardiographic waveform:

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

Continuous QC Policy

All data generated by the cardiologists are subject to an extensive and complete quality control guaranteeing an optimal quality at every step of your ECG project.

  • Coherence control performed on measurements and diagnosis
  • Intra/inter reader variability assessment
  • Quality Control 

Cardiologist pool specifically trained to ECG over-reading

  • Large (adaptable according to the study specificities: ECG number, deadline, ...)
  • Specifically trained
  • Continuous variability monitoring 

For more information please contact us: contact@biotrial.com

Expertise

Our experts are available to help you design your ECG studies. Our statisticians, medical writers, cardiologists specialized in the field of cardiovascular safety monitoring implement adapted methods of analysis and help you throughout the entire submission process.

Study Design

  • Number of subjects
  • Cross over, parallel groups

QT Interval Correction

Classical corrections are done on QT interval: Bazett and Fridericia correction. According to the study design, other corrections are possible: population or individual correction

Statistics

  • Advanced algorithms for QT correction
  • Number of subjects evaluation 
  • Study parameter definition 
  • Implementation of statistical analysis in SAS  

Report and submission

  • Protocol writing
  • Safety management
  • Report writing and submission 

Data Management

  • ECG specific data warehouse based on Clintrial® and SAS®
  • Flexibility for data transfer
  • FDA file format for digital ECG submission supported (XML)

 

For more information please contact: contact@biotrial.com