BIOSIGNA® wins multi centre clinical trial with its new paperless, fully internet based ECG core lab solution

In April 2007, BIOSIGNA® was awarded a multi centre ECG study with its highly innovative, internet based ECG core lab solution. The study includes 11 trial sites with 150 patients. All patients will be monitored using 12 lead resting ECG over the course of the trial to ensure cardiac safety. ECGs will be recorded at the trial site with the innovative PC-ECG system of BIOSIGNA and transmitted completely paperless to the central analysis solution.

“We are very pleased to announce the first application of our paperless, fully internet based ECG core lab solution – our new methods and processes will significantly increase efficiency and accuracy of cardiac safety studies. Our new patented solution has many advantages over the existing systems and processes; we do not just significantly reduce cost, but also, which is even more important, increase statistical accuracy of ECG studies for the pharmaceutical industry.” says Dr. Tosja Zywietz, the managing director of Biosigna.

The applied ECG analysis solution contains several new features and methods:
• All ECGs are automatically and paperless submitted to the central ECG solution of BIOSIGNA® from the trial sites
• In a first step analysis is done fully automatic with the well known HES® algorithm (semi-automatic mode) and all data are saved in a data warehouse
• Confirmation of ECGs is done electronically – applying new over-reading features – by experienced cardiologists
• The whole system is internet based – the location of confirming cardiologists or trial sites doesn’t matter anymore

The HES® algorithm for the “semi-automatic” analysis mode of ECGs is FDA approved since 2000 and fulfils all relevant international norms (ANSI / AMMI EC11 and IEC 60601-2-51). The internet based ECG server is fully in accordance with FDA CRF21 part 11.

Marketing of the new ECG core lab solution will officially start with MEDICA 2007 in Düsseldorf.

BIOSIGNA® – Medical Diagnostics
Lindwurmstrasse 109
80337 Munich, Germany
Tel: +49+(0)89 2371 9277
Fax: +49+(0)89 2371 9278
Email: contact@biosigna.de

BIOSIGNA® is a Munich based, innovative high-tech company specialized on cardiovascular clinical trial services and development of fully integrated solutions. Based on its long-tradition in research and development, BIOSIGNA today is one of the industry leaders for central analysis of clinical trial data for cardiac safety studies. With its new patented solutions, BIOSIGNA® will help to increase efficiency of the industry and set new standards for accuracy of cardiac safety studies.

This release was published on openPR.