
|
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).
|
|