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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.
Our procedures are fully compliant with all applicable guidelines and regulations (ICH, EMEA, FDA, Health Canada).
In addition we keep abreast of new regulatory developments and take part in the forums involving the various stakeholders (regulators, 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.)
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Key Advantages
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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.
A continuous training programme is organised for all members of staff and cardiologists.
Measurement accuracy and reproducibility are monitored on an ongoing basis.
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