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Early phase and thorough QT-studies

Through the close alliance between ExCard and CardioSec we offer you full-service solutions covering all cardiovascular aspects of your clinical trials.

A common quality assurance (QA) system and the experience derived from the evaluation of thousands of ECGs provide the basis for exact measurement and employment of new technologies and algorithms for abbreviated studies on QT prolongation tendencies as well as thorough QT studies according to regulatory guidelines.

Clinical Ward

CardioSec's clinical ward is designed in particular to perform all phases of your clinical trials. The site is equipped with validated state-of-the-art equipment including 12-channel high resolution Holter recorders as well as ECG monitors and ECG management systems.

CardioSec provides determination of various study parameters comprising bioavailability as well as pharmacokinetic and cardiac safety parameters within the same trial, thus reducing your costs and time to market.

ECG Analysis

ExCard receives all ECG data in a blinded manner from the study site through high-speed, secure data connections. Experienced cardiologists analyze all study ECGs with respect to diagnoses and characteristic ECG intervals.

All analysed ECG data are subsequently stored in a centralized study database with audit trail capabilities. The ECG data together with the pharmacokinetic parameters undergo detailed statistical analyses to identify possible drug effects.

 
 
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