Cardiabase - Information Systems & R&D


	www.cardiabase.com

INFORMATION
SYSTEMS AND R&D

cardiabase has built up a 21CFR Part 11 compliant and secure computer environment, composed of the most advanced ECG receiving stations and analysis and storage systems.

Processing includes a comprehensive range of QC checks.

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

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.

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 level of accuracy on digital data is down to 1 msec (0.25 % of QT duration).

This measurement accuracy (QTcF SDw < 6 msec in Thorough QT studies) allows smaller numbers of patients to be enrolled, leading to significant cost savings.

ECG / Holter / ABPM quality control: ECG / Holter / ABPM reading is one step in the whole process. Every piece of data is subject to more than 60 QC checks.

Audit Trails – 21 CFR Part 11 Compliance: Audit trails are crucial components of 21 CFR Part 11 compliant systems. Accordingly, procedural, technical and administrative controls have been put into place.


	Villa Alsacienne - 78, avenue du XXe Corps - 54000 Nancy \| France

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