Contract Research Organization Gains Electronic Data Capture Capabilities to Speed Information Capture and Streamline Regulatory Reporting
Redwood Shores, CA – November 24, 2008
Sermes CRO, a contract research organization (CRO) based in Madrid, Spain, has deployed Oracle® Clinical applications to support a new business unit focused on clinical trial data management, as well as plans for continued expansion in the global clinical trial market.
The company, which manages approximately eight to 12 global clinical trials annually and is involved in more than 300 studies each year, is expanding its presence in Europe through alliances with other CROs in the region as well as the launch of expanded clinical trial data management capabilities.
To support its expansion initiative, Sermes CRO required a robust, proven and highly reliable and scalable clinical data management system to replace its legacy Access Clinical Software solution.
Sermes CRO is deploying Oracle Clinical, Oracle Remote Data Capture 4.5.3 and Oracle Thesaurus Management System to facilitate process automation; effectively capture, manage and report patient data; and facilitate regulatory compliance.
Sermes CRO plans to launch two global clinical trials using Oracle Clinical and Oracle Remote Data Capture in early 2009 – the company’s first studies using the newly deployed applications.
PharmaSOL, an Oracle Certified Partner, worked with Sermes to deploy and validate the system to comply with U.S. Food and Drug Administration as well as European regulatory agency requirements.
PharmaSOL used the innovative “rapidLIVE” approach, which allowed for a quicker implementation of the full suite. The streamlined training and validation package simplified the system rollout and meant that users were immediately productive with the applications.
“As we prepared to expand our services, we needed a reliable and feature-rich clinical data management system that the pharmaceutical industry knew and trusted. Oracle Clinical applications provide us with the functionality we need to help ensure quality services to pharmaceutical organizations through accurate clinical data capture and precise information management,” said Anna Jurczynska, Director of Business Development, Sermes CRO.
“Oracle is helping emerging organizations, like Sermes CRO, accelerate insights for better health by offering proven, market-trusted solutions that speed system validation processes and support credentialing efforts as they expand the scope and reach of their services,” said Neil de Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences Global Business Unit. “With Oracle Clinical applications, Sermes CRO can deliver value to clients by offering the industry’s most robust electronic data capture and clinical data management capabilities.”
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