SPE.L Regulatory News (SPE)

3 May 2005 07:01

Sopheon PLC03 May 2005 Embargoed: 07:00hrs Tuesday 03 May 2005 Sopheon Plc ("Sopheon") Major European Hospital Selects Sopheon's Accolade To Manage Clinical Trial Operations Implementation at MCRZ Expected to Generate Additional Revenue by EnablingIncreased Levels of Trial Activity While Helping to Ensure Regulatory Compliance Sopheon, the international software and services company, announced today thatMedisch Centrum Rijnmond-Zuid (MCRZ), one of the largest general hospitals inthe Netherlands, has deployed Sopheon's Accolade solution to support an enhancedprocess for the management of clinical trials. The software will be used by theorganization's newly formed Research and Science Bureau, board of directors andmedical staff as part of a major initiative aimed at growing revenues byincreasing the volume of trial activity. MCRZ has 3,200 employees. It currently completes approximately 50 clinicaltrials annually for leading pharmaceutical companies, for universities asco-investigator, and for MCRZ investigator-initiated research. MCRZ choseSopheon's Accolade to automate the process for managing the trials and to helpadministrators implement a strategy for controlled growth of the hospital'sclinical trials business. It is expected that deployment of Accolade will alsoenable 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 ofrevenue for the hospital and our research foundation," said Paul van Es, managerof the MCRZ's Research and Science Bureau. "Over the next few years, we plan todouble our level of trial activity. To achieve that goal, we will not only haveto continue to meet demanding regulatory deadlines for trial turnaround, we willhave to deliver consistently high-quality trial data to our pharmaceuticalclients with greater efficiency than ever before. A home-grown system couldnever have handled the complete range of requirements that we face. And none ofthe alternative externally produced solutions we looked at came close tomatching Accolade's mix of essential out-of-the-box functionality. It was clearto us that the Sopheon offering was the right solution for our needs." The new European GCP (Good Clinical Practice) directive for clinical trialsrequires that once a pharmaceutical company submits a request to a hospital toconduct a trial, the hospital has 60 days in which to gain MEC (Medical EthicalCommission) approval. Failure to complete this step within the prescribedtimeframe results in a voiding of the application. By employing Accolade, MCRZexpects be able to process trial requests more quickly, helping to ensure thatthe MEC guidelines are met. In addition, use of Accolade is expected to reducetrial preparation time by approximately 80 percent, allowing MCRZ to start thetrials for its pharmaceutical manufacturing clients more quickly. "Sopheon's Accolade not only gives us a common framework for trial activityacross our entire organization, it provides a central repository for all processdeliverables," said Dr. Diederik de Lange, treasurer of the medical staff atMCRZ. "This, in turn, enables researchers and trials managers to more easilytrack the progress and cost of each trial, ensure the proper allocation ofresources and evaluate trial results. The consequent efficiency means that arelatively small staff can handle a substantial number of trials while stillmeeting client demands and the requirements of new EU directives. When aresearcher doesn't comply with these directives, it leads to his or herdisqualification which, in turn, has a big impact on the reputation of theentire hospital. We believe that our adoption of Accolade is a critical step inour efforts to further our stature as one of the Netherlands' leading clinicaltrials facilities." "During the past 15 years, the cost of developing a new drug in Europe hasincreased by more than 250 percent," said Andy Michuda, chief executive officerof Sopheon. "As a result, more and more pharmaceutical companies have shiftedtheir clinical trials activities to research facilities in emerging countrieswhere fees are lower. This has greatly reduced the volume of clinical trialsbusiness in Europe and diminished the amount of knowledge created throughscientific research. MCRZ is the latest in a growing number of preeminentEuropean research facilities that are adopting Accolade not only as a means ofachieving a best-practice process model for their trials activity, but as a wayof retaining a foothold in the pharmaceutical research industry." Sopheon Accolade(R) is a registered trademark of Sopheon plc.All other trademarks and registered trademarks are the soleproperty of their respective owners. About MCRZ Hospital With 3,200 employees and approximately 800 beds, Medisch Centrum Rijnmond-Zuid(MCRZ) is one of the largest hospitals in the Netherlands. MCRZ was recentlyformulated after a merger between two hospitals, Zuider ziekenhuis and the Claraziekenhuis, and specialises in four top clinical areas: burn care, dialysis,intervention cardiology and cardio thoracic surgery. About Sopheon Sopheon (LSE: SPE) is an international provider of software and services thathelp organizations improve the business impact of product development. TheSopheon Accolade(R) product development system automates gate- or phase-basedproduct development processes and provides strategic decision support thatallows companies to improve innovation, cut product development spending wasteand shorten time-to-market. Sopheon's Monitor software operates as a "readingrobot" that automatically reviews, filters, analyzes and pushes relevant contentto healthcare and engineering professionals to enable effective compliance withprotocols, standards and regulations. Sopheon is listed on the AIM Market of theLondon Stock Exchange and on the Euronext in the Netherlands. For moreinformation, please visit www.sopheon.com. -Ends- For further information please contact:Ron Helgeson Tel.: +1 952 851 7585Sopheon E-mail: ron.helgeson@sopheon.com Paul van Es Tel.: +31 10 2903223MCRZ E-mail: esp@mcrz.nl Bonnie Anderson/Jessica Roeber Tel.: +1 617 210 4755Bell Pottinger USA (for Sopheon) E-mail: banderson@bellpottingerusa.com jroeber@bellpottingerusa.com Andrew Tan Tel.:+44 207 245 1100Hansard Communications andy@hansardcommunications.com This information is provided by RNS The company news service from the London Stock Exchange