European Union Mandates Compliance for Clinical Research

Atrium Medical Center selects app to manage clinical trials, innovation projects

Minneapolis, MN and London — January 20, 2005 — Atrium Medical Center, one of the largest general hospitals in the Netherlands, has said that it is deploying Sopheon's Accolade solution to support implementation of a structured process for comprehensive management of clinical trials.

Use of the software is expected to help Atrium enhance management of trials activity and ensure compliance with the latest European Union (EU) clinical research regulations. Accolade will also be used by the hospital to manage innovation projects, including major capital investment initiatives.

In May 2004, new regulations went into effect across the EU aimed at establishing common guidelines for clinical-trial procedures. Atrium is using these compliance directives as an opportunity to strengthen the organization and management of its clinical-trials operations. The hospital is deploying Sopheon's Accolade at its facilities in Heerlen, Kerkrade and Brunssum. Atrium conducts approximately 70 clinical trials per year for leading pharmaceutical companies. It is anticipated that use of the software system, which will eventually handle as many as 240 trials at one time, will increase clinical-trials revenue by enabling faster trial preparation and execution, higher quality results and improved service to clients.

Sopheon also worked closely with the Atrium team to configure Accolade to fit a new, jointly developed process that incorporates elements of the Six Sigma manufacturing methodology that will be applied to management of innovation initiatives. Executives and administrators will use the software to select and support implementation of the 40 or so new projects the hospital invests in per year to improve patient care and update facilities. Current initiatives range from a multi-million dollar construction project to designing a new patient identification system.

"Pharmaceutical companies judge our clinical-trial work by the quality of the results and the speed and cost-effectiveness with which those results are delivered," said Dr. Graham Ramsay, a member of Atrium's board of directors. "Patients depend upon our ability to effect the right kinds of innovation and make the right capital investments to ensure that they receive the best available care."

Dr. Graham said Sopheon's software will integrate Atrium's processes for managing clinical trials and innovation projects, making those processes more stable, predictable and efficient. "As a consequence, we will be able to deliver high-quality results to our pharmaceutical clients more rapidly and with reduced paperwork, while making certain that the innovation projects we choose to support and implement are the ones that will most greatly benefit those who turn to us with their healthcare needs," he said.

Sopheon's Accolade is used to improve and manage the processes associated with the development of such products as new drugs and medical devices. At Atrium, Accolade will replace the manual, paper-based process structure previously used to manage clinical trials with a Web-based framework for everything from tracking schedules and budgets to assessing and allocating resources, conducting financial analyses, and examining trial results.

The system provides hospital executives, managers, clinical trial coordinators, doctors and researchers with the information support required for tactical, day-to-day management activity as well as for strategic, longer-term business decision-making. Atrium plans to extend access to the system to pharmaceutical clients interested in checking on the status of trial projects involving their products.

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