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Permanent regulatory watch

CardiaBases reading methods are regulatory compliant with the latest European and international guidelines (CPMP, FDA/ICH) and their forthcoming evolution.

A high level of expertise

A team of trained cardiologists daily works on reading improvement.
Cardiologists work at each level of study progress:
  before the study begins (designing the reading protocol for central reading),
during ECG reading (quality control),
after ECG reading (experts’ reports for controversial ECGs).

 

Quality control department

Three full time employees manage quality control at CardiaBase :
  One dedicated to GCP
One dedicated to 21 CFR compliance of IT systems
One responsible for the quality of ECG analysis

Permanent innovation

CardiaBase provides innovative solutions for ECG collection and reading, and helps sponsors shift to all-numeric ECG management. CardiaBase takes care of all logistical matters of clinical studies regarding ECG management, from data recording (rental and installation of 12-lead ECG recorders in investigation centers) to ECG transmission, reading and database export under the desired format (XML available).