Tufts-New England Medical Center Implements Medidata Solutions To Manage Five Year Clinical Trial For Heart Attack Prevention Procedure

NEW YORK and BOSTON, March 7 /PRNewswire/ -- Medidata Solutions, a global electronic clinical data management solutions provider today announced that Tufts-New England Medical Center's (Tufts-NEMC) Institute for Clinical Research and Health Policy Studies (ICRHPS) has entered into a multi-year contract to license the Company's Medidata RAVE electronic data management solution (eCDM). ICRHPS will use the RAVE technology to conduct a nationwide clinical trial to determine if an intravenous "GIK" solution of glucose (sugar), insulin, and potassium can reduce the likelihood of death from heart attack. ICRHPS has received a $36 million grant from the National Institute of Health's National Heart Lung and Blood Institute for this research and will use Medidata to ensure cost effective, accurate clinical data gathering and timely results.

Known as the IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care) Trial, the study will test whether the "GIK" solution can prevent threatening heart attacks from occurring, and for heart attacks already underway, whether GIK can decrease serious complications and death. Nationally, this five-year trial will include more than 15,400 patients.

"When we made the decision to adopt EDC to streamline this study, we set out to evaluate all the current EDC vendors", said Harry Selker, MD, Principal Investigator of the IMMEDIATE Trial and Executive Director of ICRHPS at Tufts-NEMC. "Medidata's approach best fit the needs of this complex national study."

"We continue to see world-class institutions like Tufts-NEMC implement Medidata RAVE to ensure their trials are supported by the most comprehensive electronic data management solution available", said Tarek Sherif, CEO Medidata Solutions. "Tufts-NEMC is undertaking a very important study with potentially far-reaching impact, and Medidata RAVE is designed to ensure accurate data capture is immediately available for early results and resource management."

The Tufts-NEMC ICRHPS faculty's expertise emphasizes advancing research methods and having a real-world impact on clinical care. ICRHPS is leveraging Medidata's technologies to continue this tradition. "We believe Medidata RAVE provides us with a simple solution to collecting a large volume of data. We see this use of this EDC system as the start of a long, successful relationship" said John Griffith, PhD, Co-Principal Investigator of the IMMEDIATE Trial's Data Coordinating Center and Director of Tufts-NEMC's Biostatistics Research Center.

About Medidata Solutions

Medidata Solutions understands and helps customers manage the business of electronic Clinical Data Management better than any one else. By reducing the latency of information gathering with enterprise-class workflow and web-based products, Medidata Solutions works with global life sciences and research organizations to accelerate the process of bringing life-enhancing treatments to market. Medidata Solutions' flexible applications streamline the collection, verification, consolidation and analysis of clinical research and safety data. This gives front-line clinical investigators and data managers the earliest possible visibility into data for more precise decision-making, reduced costs and better answers. To learn more about Medidata Solutions visit http://www.mdsol.com/.

About Tufts-NEMC Institute for Clinical Research and Health Policy Studies

The Institute for Clinical Research and Health Policy Studies (ICRHPS) at Tufts-NEMC encompasses programs in clinical and health policy research, training programs in clinical research, and general resources for conducting clinical research. The ICRHPS conducts research at Tufts-NEMC and other Tufts-affiliated hospitals, collaborates with research in the Tufts Schools of Dentistry, Nutrition, and Veterinary Sciences, and with institutions, organizations, and agencies in the United States and abroad. In addition to doing research, the ICRHPS and its faculty have rigorous clinical research training programs and provide a broad array of clinical research resources to assist young and established investigators' career development and research. Reflecting these functions, the Institute is composed of three divisions: the Research Programs Division, the Clinical Research Training Programs Division, and the Division of Clinical Research Resources. Further information can be found at http://www.tufts-nemc.org/.

Medidata Solutions

CONTACT: Ed Viviani of Medidata Solutions, +1-212-918-1800,eviviani@mdsol.com; or Melissa McPherson of Tufts-NEMC, +1-617-636-0200

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