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The major trade group for the global pharmaceutical industry,
Pharmaceutical Research and Manufacturers of America (PhRMA), and economic consulting firm
Analysis Group, Inc. (AG) have selected benchmark industry tools from
Medidata Solutions (NASDAQ: MDSO) as the key input for research into the costs of post-approval clinical trials.
Clinical trials are one of the costliest areas in bringing safe and effective new treatments to patients. After a medicine has been approved for initial use, pharmaceutical companies often invest further in determining its effectiveness and safety for new populations, such as pediatric patients. PhRMA and AG are analyzing the costs associated with these post-approval trials, identifying cost drivers and variations.
The research will rely on the world’s largest databases of negotiated clinical costs from
Medidata Grants Manager® and
Medidata CRO Contractor®, which have the PICAS
® and CROCAS
® databases containing hundreds of thousands of data points from actual executed protocols, investigator grants and other contracts from pharmaceutical and other research sponsors.
“Research on a new medicine often continues long after marketing approval, generating crucial information on a medicine's safety in a broader population and potential efficacy for new indications. Efficiently and effectively conducting these clinical trials is key to industry’s ability to provide new and improved treatment options to patients,” said Lori Reilly, vice president of policy and research, PhRMA. “Medidata’s benchmark cost database solutions are ideal for helping us understand factors affecting post-approval research.”
Working with AG, a widely-recognized group of health economics experts, PhRMA will deliver the key data points that will form the foundation of this research.
“We will be examining how cost factors vary across indications and uses, allowing us to build on past research,” said Genia Long, managing principal, Analysis Group. “Medidata's detailed clinical trial data allows for thorough investigation of drivers of clinical trial costs.”
Medidata Grants Manager and Medidata CRO Contractor are widely used by pharmaceutical companies, medical device companies and contract research organizations to conduct fair and efficient trial planning, budget development and grant negotiation. Considered the industry standard for measuring trial cost trends, these globally accessible analytic tools have also been used for research by the National Bureau of Economic Research and other research organizations.
“Our data-based trial planning solutions are widely used by drug companies to rein in trial costs through efficient planning, negotiation and management,” said Glen de Vries, president, Medidata Solutions. “We are very pleased that these tools are also underpinning some of the most important research in pharmaceutical economics, helping develop new industry strategies to streamline the research process.”
About PhRMAThe Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $49.5 billion in 2011 in discovering and developing new medicines. PhRMA's mission is to conduct effective advocacy for public policies that encourage discovery of important new medicines for patients by biopharmaceutical research companies.
About Analysis Group, Inc.Analysis Group, Inc. provides a broad range of economic, financial, management and litigation support consulting to corporations, government agencies, and law firms, and is a leading provider to life sciences firms of health economic analyses and outcomes research. The firm, founded in 1981, has over 500 professionals, with offices in Boston, Chicago, Dallas, Denver, Los Angeles, Menlo Park, New York, San Francisco, Washington, and Montreal.
About Medidata Solutions WorldwideMedidata 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.