IT Support and R&D

Our processing system includes a comprehensive range of QC checks

Cardiabase has built up a 21CFR Part 11 compliant and secure computer environment that includes the most advanced ECG receiving stations and analysis and storage systems.

A multi-fold internal check is performed on each database to ensure data reliability and to reduce the risks during database lock-up and / or database transfers.

Computer validation for high accuracy and reproducibility

Cardiabase delivers validated and quality assured data in strict agreement with the specific requirements of every sponsor.

ECG measurement accuracy: Normal QT values range below 430 to 450 msec, depending on the gender. Cardiabase’s level of accuracy on digital data is down to 1 msec (0.25 % of QT duration).

ECG measurement precision, We measure the QT interval with a high degree of precision as shown by a standard deviation of the baseline-adjusted, placebo-subtracted changes in QTcF that is very low, < 6 msec in Thorough QT studies. This high level of precision enables sponsors to enroll fewer patients in their studies thereby leading to significant cost savings.

Key Advantages:
 

Secure web-based access to study data.

Cardiologists’ annotations captured electronically on all ECG waveforms.

Protocol-specific metrics.

Complete 10-second electronic digital raw ECG waveforms stored electronically.