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