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Infermed and Siemens collaborate to integrate EMR and EDC at the Technical University of Munich Frauenklinik

Infermed : 07 February, 2008  (New Product)
InferMed has completed the first year of study in conjunction with Siemens and researchers at the Technical University of Munich that enables an immediate, scalable method of automatically transferring data from an electronic medical records (EMR) to an electronic data capture (EDC) system, reducing lag time and increasing efficiency.
Historically, the capture of clinical trial data has been labour intensive and error-prone, requiring data to be manually transcribed into a paper case report form or, more recently, entered manually into Internet-based data capture systems.

The innovative solution from InferMed and Siemens offers a scalable, automatic transfer of data between the electronic Medical record system and MACRO EDC from InferMed thereby overcoming interoperability challenges previously associated with systems that operate on different technical platforms or work from within distinct business environments.

The pilot implementation was designed at the Technical University of Munich’s Frauenklinik to create an automatic electronic data transfer platform for two studies focusing on women’s health. One of the studies was to evaluate the effectiveness of the various types of chemotherapy on women with breast cancer. The second study was to evaluate the diagnostic value of the use of motion correction algorithms on Magnetic resonance imaging (MRI).

By using this flexible solution, clinicians and research staff were able to automatically view, retrieve and disseminate clean data, while reducing the effort of manually collecting and entering trial data.

Preliminary results of the study show an increase of efficiency for all involved parties. Those improvements include quality improvement resultant from interfaces to all data demonstrating improved data quality and integrated processes leading to improved process quality.

The Technical University of Munich’s Medical Center has proved attractive for both researchers and trial sponsors leading to greater numbers of such trials and therefore increased population results, all of which ultimately leads to improved patient care due to the many high-quality trials being conducted there.

Professor Harbeck, Principal Investigator at The Frauenklinik commented: “The Technical University of Munich’s academic medical centre benefits greatly from using data from our existing clinical information system for clinical trial activities and we will continue to explore and use all relevant data sources at the medical centre to support our clinical research activities. Complying with national and international data safety regulations, external clinical trial sponsors can now access higher quality data more quickly and in an electronic format.”

“Having a solution that significantly improves study efficacy whilst enabling real-time data availability for clinical trial sites can only serve to revolutionise study management,” said Duane Lawrence, CEO InferMed. “Enabling adaptive mid-trial alterations and ensuring consistency across study sites will eventually yield more timely and accurate outcomes.”

“We are extremely proud to be part of this innovative solution that will ultimately benefit more timely and personalised patient care.”

Dr Gudrun Zahlmann, the project lead from Siemens, Healthcare sector said: “This innovative solution has proven to be efficient in reducing the time effort of the study nurses for data documentation to one third compared to the old paper-based process. All clinical trial related data is available within 24 hours in a high quality, clean format and in accordance with the regulatory requirements. We have found two highly motivated and very reliable partners in the Frauenklinik of the Technical University Munich and in InferMed. This relationship together with the innovative and challenging solution made this pilot a success. This could prove to be the blueprint for the overall HER - EDC integration for clinical trials.”
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