Six Sigma Clinical Trials Supports EU Regulations While Enabling Innovation ...

Six Sigma Clinical Trials Supports EU Regulations: Atrium Medical Center Selects Sopheon's Accolade Solution to ...

From Business Wire (press release), CA ... closely with the Atrium team to configure Accolade to fit a new, jointly-developed process incorporating elements of the Six Sigma manufacturing methodology ...

... Sopheon, the international software and services company, announced today that Atrium Medical Center, one of the largest general hospitals in the Netherlands, 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. ...

Sopheon (LSE:SPE) is an international provider of software and services. The Sopheon Accolade product development system automates gate- or phase-based product development processes and provides strategic decision support that allows companies to improve innovation, cut product development spending waste and shorten time-to-market. Sopheon's Monitor software operates as a "reading robot" that automatically reviews, filters, analyzes and pushes relevant content to healthcare and engineering professionals to enable effective compliance with protocols, standards and regulations. Sopheon is listed on the AIM Market of the London Stock Exchange and on the Euronext in the Netherlands.

With 3600 employees and 1230 beds, Atrium Medical Center (Atrium) is one of the largest employers in the south of the Netherlands. In 2004 Atrium celebrated its 100-year anniversary. It has a national reputation for hospital innovation, and has recently participated in experimental studies on reducing patient wait-lists, increasing care-delivery production, implementing new budgetary systems and improving patient safety. In 2003, supported by a EUR 187 million budget, Atrium registered 28,000 clinical admissions, 24,000 day admissions and 432,000 patient visits to its policlinics. Atrium's focus on patients, professionalism, and continuity and effectiveness of treatment ensures that the quality of care it provides remains on the highest levels.

Additional resources on Six Sigma clinical trials that support European Union EU regulations ...

Cognizant's Differentiators - Life Sciences Practice: electronic data capture product in over 160 clinical trials. ... Experience in execution of Six Sigma projects. ... and data investments to support sales, marketing ...

Conferences, Workshops, Meetings: goal of addressing reasons for clinical trial failure earlier ... discuss how the deployment of Six Sigma could help ... to application in a clinical setting, allowing ...

Concurrent engineering in a pharmaceutical firm: a case study: File Format: PDF/Adobe Acrobat ... new molecules developed by DRL undergoing clinical trials. ... technical and regulatory support to customers ... product development using six sigma methodology with a ...