NEWS - 2 February 2008
InferMed announces successful collaboration with Siemens in integrating Electronic Data Capture (EDC) and Electronic Medical Records (EMR) at the Technical University Munich
New system enables better integration of medical records with clinical trial data.
InferMed Ltd, the leading global provider of advanced decision support and data capture solutions for clinical research and practice, today announced that they have successfully completed the first year of study in conjunction with Siemens AG and researchers at the Technical University of Munich that enables an immediate, scalable method of automatically transferring data from an EMR to an EDC system, reducing lag time and greatly 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. This 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 highly 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 that “The Technical University of Munich’s academic medical center 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 center 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 Ltd. He continued “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 AG, Healthcare sector said that “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 Ltd. This relationship together with the innovative and challenging solution made this pilot a success. This could prove to be the blueprint for the overall EHR – EDC integration for clinical trials.”
About InferMed Ltd
Formed in 1999 InferMed is the leading global provider of advanced decision support and data capture solutions for clinical research and practice. InferMed offers a range of highly innovative software solutions for collecting and managing data. Through both their MACRO EDC application and Arezzo® decision support technology, InferMed’s products are designed to improve patient outcomes and deliver personalised drug and other therapies to healthcare providers.
For more information visit www.infermed.com
About The Technical University of Munich
The Technical University of Munich’s Rechts der Isar hospital serves Munich and the world with a highly skilled team of dedicated doctors, nurses, research scientists, and technical assistants. With a workforce of over 3,700 personnel, the University hospital is a renowned center for the care of the sick, for medical research, and for the teaching of medicine. Rechts der Isar comprises more than 31 separate clinics and departments treating some 45,000 inpatients and 160,000 outpatients annually. Its department of obstetrics and gynecology, under the guidance of Prof. Dr. Marion Kiechle and her team is a certified breast center and is heavily involved in clinical research and clinical trials to bring innovative procedures to the patient, such as uPA/PAI measurements for chemotherapy decision support.
A 1,100-bed hospital, Rechts der Isar covers the entire spectrum of modern medicine with state-of-the-art efficiency. Through the close cooperation between healthcare and research, the latest advances in medical techniques can be quickly integrated into patient treatment procedures.
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