Siemens Helps Streamline Clinical Trial Process

Pilot Study Demonstrates New, Scalable Method of Automatically Transferring Data from EMR to EDC System, Reducing Lag Time and Increasing Efficiency

Malvern, Pa., Sep 19, 2006 - Researchers at the Technical University of Munich and Siemens Medical Solutions (www.siemens.com/medical) have developed a method of electronically transferring clinical data gathered at the point of care for use in prospective clinical trials. Through this unprecedented process, clinical trial research results can be documented more efficiently, saving both time and money.

Historically, the capture of clinical trial data has been labor intensive and error-prone, requiring data to be transcribed into a paper case report form or, more recently, entered manually into Internet-based data capture systems. This innovative solution offers a scalable, automatic transfer of data between an electronic medical record (EMR) and an electronic data capture (EDC) system, overcoming interoperability challenges associated with systems that operate on different technical standards and work within distinct business environments. Enabling immediate data transfer, the solution is being tested in a pilot study that was initiated in June 2006. Preliminary results of this pilot will be released today at the ExL Pharma’s 2nd Merging Electronic Health Record and Electronic Data Capture Conference in Washington, D.C., and during an eClinical Forum presentation in Paris on Sept. 20.

“The Technical University of Munich’s academic medical center is using a hospital information system for administrative and clinical processes to ensure high quality patient care,” said Dr. Ulrike Schwarz-Boeger, Project Manager, Technical University of Munich. “We see a great benefit in 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. External clinical trial sponsors can now access higher quality data more quickly and in an electronic format.”

The pilot implementation was designed to create an automatic electronic data transfer platform for two studies focusing on women’s health. One of the trials is evaluating the effectiveness of the various types of chemotherapy on women with breast cancer. The second trial will evaluate the diagnostic value of the use of motion correction algorithms on magnetic resonance imaging (MRI), and is slated to begin in October.

The solution achieves the goal of connecting disparate systems using Siemens OPENLinkTM and Soarian® Portal. Now, clinicians and research staff can automatically view, retrieve and disseminate clean data, while reducing the effort of manually collecting and entering trial data. The solution is highly flexible and compatible with any EMR product and EDC system, such as InferMed’s (www.infermed.com) MACRO technology, which is used in this pilot.

“Using our healthcare process ’know how’ and deep understanding of the varying regulatory and standards environments, we’ve overcome a significant hurdle in the evolutionary process of clinical efficiency,” said Janet Dillione, president, Healthcare Information Technology Division, Siemens Medical Solutions. “We know that hospitals rely on research funding - it can be up to 30 percent of their income - and pharmaceutical companies rely on the clinical and research expertise of leading healthcare systems. This successful pilot is a crucial step in bringing these two worlds closer for the universal benefit of more timely patient care.”

“Having a solution that significantly improves efficiency and enables real-time data availability for clinical trial sites will increase motivation and enhance the quality of studies,” said Hugh Donovan, General Manager, Clinical Trials Business, Siemens Medical Solutions. “Today, the pharmaceutical industry manages many studies looking through the rear view mirror. The availability of real-time data, as demonstrated through this pilot, will transform study management, enabling mid-course corrections and ensuring consistency across study sites, ultimately yielding more timely and accurate outcomes.”

The Soarian Portal provides reliable, Web-based access to patient information through a secure, personalized portal. Single sign-on capability enables the integration of multiple applications and content to meet varying clinical workflow needs. Siemens OPENLink is an acclaimed interface engine that has been delivering integration of disparate systems to the healthcare industry for over 20 years. Well-known for its intuitive graphical user interface and leadership in standards-compliant middleware, it supports the integration of Web-based standards, and health system and research standards such as XML, HL7, SSL, X12, DICOM and CDISC.

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 is well recognized for its activities in clinical care, research and training. Prof. Dr. Marion Kiechle and her team serve patients with a broad range of diagnostic and therapeutic procedures. In addition to a wide-range of therapies for obstetric and benign gynecologic diseases, the department places a strong emphasis on the treatment of gynecological malignant tumors, including classic and plastic surgery, and chemotherapy. The department 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.

About Siemens Medical Solutions

Siemens Medical Solutions of Siemens AG (NYSE:SI) with headquarters in Malvern, Pennsylvania, and Erlangen, Germany, is one of the largest suppliers to the healthcare industry in the world. The company is known for bringing together innovative medical technologies, healthcare information systems, management consulting, and support services, to help customers achieve tangible, sustainable, clinical and financial outcomes. Employing approximately 33,000 people worldwide and operating in more than 120 countries, Siemens Medical Solutions reported sales of 7.6 billion EUR, orders of 8.6 billion EUR and group profit of 976 million EUR for fiscal 2005. More information can be obtained by visiting www.usa.siemens.com/medical-pressroom.

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Kristen Saponaro

Siemens AG

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