CIMdata PLM Industry Summary Online Archive
3 May 2005
Implementation Investments
Major European Hospital Selects Sopheon's Accolade To Manage Clinical Trial Operations
Sopheon announced that Medisch Centrum Rijnmond-Zuid (MCRZ), one of the largest general hospitals in the Netherlands, has deployed Sopheon's Accolade solution to support an enhanced process for the management of clinical trials. The software will be used by the organization's newly formed Research and Science Bureau, board of directors and medical staff as part of a major initiative aimed at growing revenues by increasing the volume of trial activity.
MCRZ has 3,200 employees. It currently completes approximately 50 clinical trials annually for leading pharmaceutical companies, for universities as co-investigator, and for MCRZ investigator-initiated research. MCRZ chose Sopheon's Accolade to automate the process for managing the trials and to help administrators implement a strategy for controlled growth of the hospital's clinical trials business. It is expected that deployment of Accolade will also enable MCRZ's medical staff to accelerate trial preparation and execution time, an important aspect of ensuring compliance with new European Union (EU) regulations for clinical trial procedures.
"Our clinical trials business represents an increasingly important source of revenue for the hospital and our research foundation," said Paul van Es, manager of the MCRZ's Research and Science Bureau. "Over the next few years, we plan to double our level of trial activity. To achieve that goal, we will not only have to continue to meet demanding regulatory deadlines for trial turnaround, we will have to deliver consistently high-quality trial data to our pharmaceutical clients with greater efficiency than ever before. A home-grown system could never have handled the complete range of requirements that we face. And none of the alternative externally produced solutions we looked at came close to matching Accolade's mix of essential out-of-the-box functionality. It was clear to us that the Sopheon offering was the right solution for our needs."
The new European GCP (Good Clinical Practice) directive for clinical trials requires that once a pharmaceutical company submits a request to a hospital to conduct a trial, the hospital has 60 days in which to gain MEC (Medical Ethical Commission) approval. Failure to complete this step within the prescribed time frame results in a voiding of the application. By employing Accolade, MCRZ expects be able to process trial requests more quickly, helping to ensure that the MEC guidelines are met. In addition, use of Accolade is expected to reduce trial preparation time by approximately 80 percent, allowing MCRZ to start the trials for its pharmaceutical manufacturing clients more quickly.
"Sopheon's Accolade not only gives us a common framework for trial activity across our entire organization, it provides a central repository for all process deliverables," said Dr. Diederik de Lange, treasurer of the medical staff at MCRZ. "This, in turn, enables researchers and trials managers to more easily track the progress and cost of each trial, ensure the proper allocation of resources and evaluate trial results. The consequent efficiency means that a relatively small staff can handle a substantial number of trials while still meeting client demands and the requirements of new EU directives. When a researcher doesn't comply with these directives, it leads to his or her disqualification which, in turn, has a big impact on the reputation of the entire hospital. We believe that our adoption of Accolade is a critical step in our efforts to further our stature as one of the Netherlands' leading clinical trials facilities."
"During the past 15 years, the cost of developing a new drug in Europe has increased by more than 250 percent," said Andy Michuda, chief executive officer of Sopheon. "As a result, more and more pharmaceutical companies have shifted their clinical trials activities to research facilities in emerging countries where fees are lower. This has greatly reduced the volume of clinical trials business in Europe and diminished the amount of knowledge created through scientific research. MCRZ is the latest in a growing number of preeminent European research facilities that are adopting Accolade not only as a means of achieving a best-practice process model for their trials activity, but as a way of retaining a foothold in the pharmaceutical research industry."
With 3,200 employees and approximately 800 beds, Medisch Centrum Rijnmond-Zuid (MCRZ) is one of the largest hospitals in the Netherlands. MCRZ was recently formulated after a merger between two hospitals, Zuider ziekenhuis and the Clara ziekenhuis, and specializes in four top clinical areas: burn care, dialysis, intervention cardiology and cardio thoracic surgery.
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