CIMdata PLM Industry Summary Online Archive
10 October 2007
Implementation Investments
Leading European Center for Clinical Trials Research Selects Sopheon's Accolade® System
Sopheon announced that the University Medical Center (UMC) Utrecht, represented by its division the Julius Center, has selected Sopheon's Accolade product life cycle management system to support its processes for conducting clinical trials. Julius' research program is comprised of initiatives sponsored by leading pharmaceutical companies, universities and the government, including trial investigations that involve other UMC divisions.
Pharmaceutical companies are expected to increase spending for outsourced research and development services by almost 15% annually for the next five years. The core of this trend is the outsourcing of clinical development, which more and more pharmaceutical executives see as a way to reduce costs and increase efficiency. The outsourced model also makes it possible to complete trials more quickly. The global growth in demand for outsourced clinical trial services is fueling new levels of business opportunity for independent research operations such as the Julius Center. Julius is a particularly attractive alternative because it has unique competencies in the management of complex, global clinical trials involving multiple medical centers.
More than 2,000 clinical trials are completed across UMC Utrecht each year, and Julius conducts or oversees a large portion of these investigations. The adoption of Accolade will help the organization handle a steadily growing volume of trial activity. Accolade provides an automated process structure that will enable the Center's research and program management staff to accelerate trial preparation and execution. The system's data protection and management capabilities will contribute to ensuring trial security and quality, and facilitate more efficient collaboration among researchers. Implementation of the system will also support compliance with European GCP (Good Clinical Practice) directives for clinical trial execution.
"As acceptance of the outsourced model for clinical trials management has increased among public and private organizations, our project pipeline has become deeper and more complicated," said Robert Veen, data management manager for the Julius Center. "Our deployment of Accolade has allowed us to take project data previously recorded and stored on isolated tools like spreadsheets, and consolidate them in a single, easily accessed repository. The flexibility of the Accolade system, reflected in the fact that we can configure it on our own, provides us with a platform that can accommodate multiple processes and a nearly limitless range of specific process requirements. Accolade gives us confidence that our trials will be executed consistently and with the kind of rigorous quality control that will ensure the accuracy and reliability of their outcomes. Sopheon's solution will allow us to take the professionalization of our research processes to a whole new level."
"The University Medical Center Utrecht is an international symbol of excellence in scientific research and education," said Huub Rutten, Sopheon's vice president of research and development. "Their clinical trial operations are, like Sopheon and Accolade, focused on helping organizations get better products to market faster. They have built their success on quality performance and an abiding commitment to the pursuit of best practices. We are proud to be able to contribute even indirectly to the invention of the important new medicines and treatments that result from their efforts."
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