(openPR) - XClinical GmbH and BIOSIGNA GmbH are integrating their systems for the implementation of clinical trials – the new system is based on the software MARVIN from XClinical and on Biosigna’s central ECG management platform.

XClinical, an EDC vendor for all types of clinical studies, and Biosigna, a leading provider of ECG management systems and ECG services for clinical trials, are going to co-operate.

An undesired side effect of drugs can be the negative impact of the cardiac repolarisation in the heart which can, at worst, lead to fatal arrhythmias. Since 2005 the FDA has demanded the verification of the cardiovascular tolerability for the admission of all new drugs (independent of their indication) in the framework of so-called QT/QTc-studies. In the framework of these studies the vital parameters can be verified with the help of the ECG.
Biosigna has developed a central ECG management system with which such studies can be conducted very efficiently and cost-saving. The bases of the system are intelligent algorithms which enable the quick and reliable interpretation of the vital parameters of the ECG. XClinical and Biosigna are developing a fully integrated system on the basis of XClinical’s EDC Software MARVIN, which integrates Biosigna’s central ECG services automatically into clinical trials. The software MARVIN, which is fully based on CDISC standards, is able to integrate all kinds of binary data and one of the first systems enabling an integration of central ECG services.

BIOSIGNA® is an expert for ECG services and for the development of ECG systems. The focus is on the implementation of innovative concepts for clinical studies, hospitals, surgeries and home care.
The intelligent software algorithms for automatic measurement and interpretation have been implemented by leading medical equipment manufacturers for years.

XClinical is a modern and professional Munich-based EDC vendor for all types of clinical studies. The company develops and distributes MARVIN, an Internet-based Software for Electronic Data Capture (EDC), Clinical Data Management (CDM) and Clinical Trial Management (CTM).
More and more pharmaceutical and biotechnology companies, but also medical devices manufacturers are using MARVIN, the data of more than 25,000 patients in 26 simultaneous studies have been documented until today.

Eva Boscher, XClinical GmbH, Phone: 089 / 452277-5210, eMail: press@xclinical.com
Dr. Tosja K. Zywietz, Biosigna GmbH, Phone: 089 / 54842111, eMail: contact@biosigna.de