Quality Assurance & Compliance

Our procedures are fully compliant with all applicable guidelines and regulations (FDA, ICH, EMEA, Health Canada).

Cardiabase has a dedicated quality assurance department that takes responsibility for GCP / SOP management / internal and external audits, 21 CFR part 11 compliance and Computer Systems Validation and other quality assurance issues pertaining to ECG analysis.

Cardiabase delivers validated and quality assured data in strict agreement with the specific requirements of every sponsor and is certified and experienced in submitting digital ECG data to the FDA ECG Warehouse.

In addition we keep abreast of new regulatory developments and participate in various forums involving all stakeholders in the field of CV safety assessment (regulators, academics, ECG Labs, clinicians representing the pharmaceutical industry, ECG device manufacturers).

Comprehensive audit trails enable us to monitor the study progress and produce detailed status reports, available on-line, and monitor the ECG analysis process at each individual step (receipt, technical review, medical review, validation, etc.)

Key Advantages:

All our readers attend an initial comprehensive training program followed by continuous performance reviews and education.

Measurement accuracy and reproducibility are monitored on an ongoing basis.