OpenClinica to Power Major European Trials, Public/Private European Consortium Signs on with OpenClinica

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OpenClinica has contracted with the SAFE-T Consortium to provide electronic data capture for a series of clinical trials across several sites in Europe and Israel.

By using a common EDC system from OpenClinica, we will reduce efforts in mapping collective data into a common data format.

OpenClinica, the world’s most popular open source clinical trials software for web-based electronic data capture (EDC) and clinical data management (CDM), has contracted with the SAFE-T Consortium. The SAFE-T Consortium is a unique public-private partnership of the European pharmaceutical industry which includes: Pfizer, Novartis, Lilly, Amgen. The Consortium is also comprised of 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 in an interview. “By using a common EDC system from OpenClinica, we will reduce efforts in mapping collective data into a common data format.

Ben Baumann OpenClinica’s Director of Business Development, says OpenClinica 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, start-up, 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.

About SAFE-T

SAFE-T is working to address the current lack of sensitive and specific clinical tests to diagnose and monitor drug-induced injury to the kidney, liver and vascular systems in man, which is a major hurdle in drug development.

Therefore, many promising candidate drugs with pre-clinical kidney, liver or vascular toxicity signals of unknown relevance do not enter the clinical phase, as no sensitive tests exist to allow timely detection of patient safety signs before irreversible injury occurs. New tests based on biomarkers will enable studies to assess whether these drugs are safe to ‘translate’ into clinical use. Furthermore, the new translational safety biomarkers will allow the identification and management of side effects of drugs throughout drug development helping to reduce the risk of developing medicines and improving the safety management of patients.

SAFE-T work generally falls under the goal of creating methods to enable personalized medicines that improve public health. For more information see http://www.imi-safe-t.eu/.
About OpenClinica®

OpenClinica enhances the productivity of clinical trials through commercial open source software. Trusted by hundreds of biopharmaceutical companies, contract research organizations, academic, and government organizations worldwide, the OpenClinica software facilitates electronic data capture and data management, increasing the speed of collection and quality of data in clinical trials. OpenClinica supports HIPAA, 21 CFR Part 11, and other regulatory guidelines and is designed as a standards-based, extensible, and modular platform. For more information – including product downloads – visit http://www.openclinica.com or follow @OpenClinica on Twitter.

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Matt Ellis

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