AMPS LLC is proud to announce the release of TrialPerfect version 3.0.
TrialPerfect is the back-end database system offered by AMPS that complements its well-known product CalECG the AMPS on-screen measurement application, thus offering a complete solution for ECG measurements and related applications in clinical trials.
The main advantage of CalECG/TrialPerfect is to provide a professional, secure and user-friendly client/server environment for the storage, analysis, interpretation, validation and review of ECG traces in the context of clinical trials. TrialPerfect is “21 CFR Part 11” compliant.
TrialPerfect v 3.0 offers a user-friendly Web interface whereby the management of annotations is completely handled by the back-end process and is traceable through a complete audit trail. The application supports all ECG file formats supported by CalECG, such as Mortara E-Scribe XML, Muse XML, HL7 XML and many others. The system also allows for fully configurable intra-reader and inter-reader variability assessment for quality purpose.
The new version of TrialPerfect offers the following major enhancements:
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- Increased safety for completed studies: it now requires two people to authorize the reopening of a study
- Affords Project Managers the ability to generate customized PDF report
- Interpretative statements are grouped in physiologic categories
- An added ability to highlight annotation caliper with keyboard keys in CalECG
- It is now possible to highlight abnormal annotation values in CalECG
- Ability to annotate TpTe, QTP, JT, JTP and Pdur measurements
- Enhanced linkage to FAT-QT, with the possibility to use QRS & PR intervals for classification
- Possibility to apply the FDA open-source algorithm ECGLib for the measurement of JTp/TpTe intervals