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The U.S. Department of Health and Human Services (HHS) and consulting firm Eastern Research Group, Inc. (ERG) have selected the comprehensive trial cost database products from Medidata Solutions (NASDAQ: MDSO) to drive research into improving the clinical trial process industry-wide. Through Medidata Grants Manager® and Medidata CRO Contractor®, HHS will have access to Medidata’s extensive proprietary databases containing information from over 275,000 negotiated clinical site grants and almost 9,000 outsourced R&D contracts.
In support of HHS’ goal of bringing health-related innovation to the public faster, ERG will analyze Medidata’s trial cost data to identify factors that delay or derail clinical studies. ERG will also assist HHS in assessing the economic benefit of implementing policies that encourage more streamlined clinical trials for the efficient delivery of safe and effective new therapies.
Medidata Grants Manager and Medidata CRO Contractor data solutions are widely used by pharmaceutical companies, contract research organizations (CROs) and academic researchers to identify prevailing rates for trial planning, budget development and grant negotiation. Medidata Grants Manager’s database, PICAS®, and CRO Contractor’s database, CROCAS®, contain hundreds of thousands of data elements derived from actual negotiated contracts, analyzable at any combination of therapeutic level, phase or geography, in easy-to-use computer-based analytic tools. With this breadth of globally accessible real-world information, these databases have become an industry standard for measuring trial cost trends.
The HHS and ERG research will be conducted over the next several months, with results expected by the end of this year.
Over the past several years, clinical trial cost data from Medidata Grants Manager and CRO Contractor have been relied on not only by pharmaceutical, biotech and medical device companies, but also by government, academic and non-profit institute researchers analyzing the industry. Recent customers include the National Bureau of Economic Research, which is using the data to develop a trendable cost index for clinical trials; and Pharmaceutical Research and Manufacturers of America (PhRMA), the major trade group for the global pharmaceutical industry, who, along with economic consulting firm Analysis Group, Inc., is using the industry data to research the costs of post-approval clinical trials.