Following the introduction of the concept papers on QTc prolongation in 2001 (www.fda.gov), it became clear that cardiovascular safety assessment would become a critical step in the drug development process. Without demonstrating the effect on QTc prolongation, the Clinical Trial industry runs the risk of a delay in approval of their compounds and possible denial.

Cardionics quickly realized that the future would be digital and this is where it has focused its activity. Having offered digital ECG solutions since 1984, Cardionics has become a leader in the field.

In addition, we offer fully digital capabilities throughout the recording, transmission and interpretation of ECGs.

From networking of the ECG software’s to the technical assistance or the capability to dissociate the place of ECG acquisition to the validating place, you can count on our know-how.

We offer innovative and flexible solutions to configure a program that’s right for you.

ECG acquisition Phase I: the CardioPlug.

The CardioPlug device has been specifically developed for the "First-In-Man" administration studies giving a special focus on the patient safety during the ECG acquisition. Indeed, the acquisition of the ECG data is realised in real-time and stored on the PC hard disk. In parallel, the investigator can visualise the 12 leads on the screen placed beside the patient’s bed.The investigator intervenes at any time to amplify or to request the analysis of the leads or the printing. A study-specific configuration files, including visit type list and custom fields can be foreseen following the specific protocol of the study.

ECG acquisition Phase III and IV: the CarTouch.

At the cutting edge of digital technology, the CarTouch device is suitable for both Phase III and IV studies enabling a consistent approach throughout the clinical development of a drug.

The device is a portable 12-lead, digital ECG recorder. Its weight has been reduced to allow easy worldwide delivery in short delays.

The CarTouch fully operates the patients and visits file management. Depending on the study protocol, the order and the type of visit to be performed can be pre-programmed. The ECG’s are transferred via a simple phone line (25 sec/ECG).

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For ECG Central Reading Centres:

The technologies developed by Cardionics make it possible to install a 100% digital cardiologic data workflow, from ECG recording to database export. Recordings are performed in investigation centres on digital devices, transmission is performed via modem to the CRO’s server.

Software have been developed for interpreting digital ECG’s acquired by the Cardionics devices. The software allows:

• Fully automated interpretation prior to the manual cardiologist review.
• Several methods for QT analysis: superimposed waveforms and tangent methods.
• XML, TXT or PDF database exports.

Cardionics software is compliant to all regulations (including 21 CFR part 11).