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AMPS has been investing for the last 17 years more than 50% of its annual revenues in Research and Development activities whereby developing and offering a set of software tools dedicated to the manual and automated analysis, processing, and quality assessment of large amounts of ECGs/Holters, as well as for the viewing of digital ECG traces in the clinical/hospital environment, in compliance with the FDA regulations. AMPS is nowadays the leader in the industry and it is estimated that more than 50% of the ecgs submitted each year to the FDA in the context of clinical trials are processed using AMPS software tools.
Given its background AMPS is therefore ideally situated to offer services to the CRO/Pharma industry in a number of areas including, but not limited to:
- Conversion of ecg paper traces (or scanned images) into digital HL7 FDA xml ecg files
- Conversion of proprietary digital ecg files formats into the HL7 FDA xml ecg format
- Validation of HL7 FDA xml ecg and continuous recording ecg files prior to submission to the FDA ECG Warehouse
- Submission of HL7 FDA xml ecg files to the FDA ECG Warehouse
In addition AMPS can offer to Sponsors secondary analysis of already submitted or halted studies by performing state-of-the-art analysis such as:
- HRV
- Holter Bin
- Beat to Beat (B2B)
For further information or questions please contact: AMPS.Services@amps-llc.com
.png "HL7 ECG Format Verification and FDA ECG Warehouse Submission")
.jpg "Secondary Analysis")
