The FINANCIAL — 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.
According to Oracle, 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.