CorWeb® – paperless ECG: everywhere at any time

In 2007, BIOSIGNA® was awarded a multi-centre ECG study with its highly innovative, internet-based ECG core lab solution CorWeb®. The study included 11 trial sites with 150 patients. All patients were monitored using 12 lead resting ECG over the trial course to ensure cardiac safety. ECGs were recorded at the trial site with the innovative PC-ECG system of BIOSIGNA® and transmitted to the central analysis solution – without any need of paper.

CorWeb® which has been developed in compliance with 21 Code of Federal Regulations (CRF) Part 11 as well as the FDA guidelines for the use of electronic systems in clinical trials, features the HES® ECG algorithms for automatic or semi-automatic analysis of resting (FDA approved since 2000), Holter (real 12 lead!) or rhythm ECGs. With this innovative ECG validation scheme, BIOSIGNA® has set new standards in terms of reduced inter- and intra-reader variability.

The new patented solution has many advantages over the existing systems and processes: CorWeb® does not only reduce cost significantly, but also, even more important, increases statistical accuracy of ECG studies for the pharmaceutical industry.

Trial Set-up and Management
Since trial success and quality do not only depend on the selected technology, but also on the humans controlling set-up and processes, BIOSIGNA® invests a lot in education and training of its trial managers in order to guarantee optimum performance and quality to the customer.

BIOSIGNA® hasimplemented a solid set of standard operating procedures (SOPs) to ensure faultless operation, starting from the first definition of a trial to the final analysis of acquired cardiovascular data.

BIOSIGNA® Research and Development Services
Every drug and every trial is different – it is hard to design a solution that meets all requirements at the same time. CorWeb® is designed in such a way that individualized changes are possible at low cost. Using in-house developed technology, BIOSIGNA® is in the unique position to offer customized solutions in short time. Before setting up trials, BIOSIGNA®  managers define the client’s requirements in detail and take responsibility for implementation and validation in due time.

BIOSIGNA GmbH
Clinical Services
Lindwurmstrasse 109
80337 Munich (Germany)
www.biosigna.com