Medidata Solutions Selected to Support U.S. Government Research on Drug Development Costs

HHS National Research Effort Will Rely on Medidata Databases to Improve Clinical Trial Process

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. Uniquely, 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.

• “Medidata’s PICAS and CROCAS databases are the perfect inputs to our research, providing the broadest, most comprehensive collection of real-world negotiated trial costs that can be disaggregated and examined,” said Aylin Sertkaya, vice president, ERG.

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.

• “We are delighted to have HHS leveraging the Medidata platform in the pursuit of more efficient clinical trials, with the ultimate goal of getting effective therapies to the patients who need them,” said Glen de Vries, president, Medidata Solutions. “While our data products are used by a broad set of life sciences companies to efficiently plan and manage their trials on a daily basis, they are also increasingly a key input for the vital research driving innovative improvements on an industry-wide scale.”

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About U.S. Department of Health & Human Services (HHS)

HHS is the United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. HHS represents almost a quarter of all federal outlays, and it administers more grant dollars than all other federal agencies combined.

About Eastern Research Group, Inc. (ERG)

ERG is a multidisciplinary professional services firm with a proven track record in delivering high-quality, technically sophisticated, and quick-response scientific, technical, and outreach support in the areas of policy and economic analysis, program assessment, evaluation studies, data collection and analysis, performance measurement, technical assistance, environmental and public health assessment, website and publication development. ERG’s clients include the U.S. Department of Health and Human Services (DHHS); Agency for Toxic Substances and Disease Registry (ATSDR) and the Food and Drug Administration (FDA); as well as numerous offices and divisions throughout the U.S. Environmental Protection Agency (EPA), the U.S. Department of Energy (DOE), and the U.S. Occupational Safety and Health Administration (OSHA).

About Medidata Solutions Worldwide

Medidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of customers’ clinical trials. Medidata’s advanced platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. Our diverse life science customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.

Contact:

Lois Paul and Partners
Susan McCarron, 617-986-5767
Susan_McCarron@lpp.com