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Regulatory Recommendations

Recent regulatory recommendations (ICH-E14) have significantly impacted the way that studies are designed. For the purpose of a „thorough QT study“ thousands of ECGs have to be recorded in a short period of time. Modern technical equipment enables us to deal with huge volumes of ECG data. Our capacity to evaluate ECGs currently exceed 20.000 recordings per month.

Phase I-IV clinical trials

ExCard Research has specialized in the analysis and interpretation of ECGs from phase I-IV clinical trials using:

> 12-lead ECGs (including continuous, high-resolution 12- lead Holter recordings) for Phase I–IV studies and thorough QT trials
> arrhythmia analysis from 24- or 48-hour Holter recordings


Evaluating new parameters

As ExCard Research is a scientifically driven ECG core lab, we are
continuously looking for new ECG parameters that may help to assess the cardiac safety of new drugs.

New parameters on which we currently focus include:

> beat-to-beat variability of the QT interval (including Poincare plotting)
> beat-to-beat-assessment of the area under the T wave
> assessment of the restitution and hysteresis of the QT interval
> categorization of T wave morphology and assessment of the dynamics
of beat-to-beat changes T wave morphology

Advanced analysis options

We also offer the following analyses:

> heart rate variability (HRV) in time- and frequency-domain
> evaluation of atrial fibrillation cycle length (AFCL)
> Implantable cardioverter defibrillator (ICD) memory analysis. Visualization and analysis of stored electrograms and documentation of the rate and detection criteria

These analyses are performed using the following ECG recording options:

> standard 12-lead recorders
> 24-hours, 12-lead digital continuous recorders
> 48-hours, 12-lead digital continuous recorders
> 24-hours, 12-lead digital continuous high-resolution recorders
(1024 Hz)
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