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OpenClinica to power major European trials

Friday, June 17, 2011

OpenClinica, a Waltham, Mass.-based maker of open source clinical trials software for web-based electronic data capture (EDC) and clinical data management (CDM), has contracted with the SAFE-T Consortium in Europe.

The Consortium is a unique, public-private partnership of the European pharmaceutical industry, academics and small and medium enterprises working to qualify translational safety biomarkers for drug-induced kidney, liver and vascular injury to enable quicker and safer evaluations of potential new medications in patients.

Over the next three years, SAFE-T will conduct clinical trials in several sites in Europe and Israel. It is the Consortium’s largest undertaking to date and is designed to assist the pharmaceutical industry in its quest to develop new biomarkers for the early detection of drug-induced kidney, liver and vascular injuries.

“We assume that OpenClinica will help us streamline the process. If every study were viewed as a separate project as is common within large pharmaceutical companies, we would not have the resources for efficiently collecting and managing essential data,” said Nicole Schneiderhan-Marra, project manager of the NMI Natural and Medical Sciences Institute. “By using a common EDC system from OpenClinica, we will reduce efforts in mapping collective data into a common data format.”

OpenClinica’s Director of Business Development Ben Baumann said, the company is able to provide efficiencies by standardizing on a common technology built on open standards, and using a single deployment of that technology for the customer’s benefit.

“This is attractive for the Consortium because they will only have to master one system, and they can build CRFs (case report forms) and SOPs only once and then re-use them as necessary. This eliminates a lot of redundancy, while accelerating study startup and ensuring higher quality trials.”

The Consortium signed to use OpenClinica’s Enterprise solution. OpenClinica Enterprise is the commercially supported version of the OpenClinica open source technology.

 

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