Medidata Solutions Helps RTI International Address Evolving Research Technology Needs
Medidata Rave® EDC/CDM Successfully Introduced to Support Data Coordinating Services for an Increased Volume of FDA-Regulated, NIH-Funded Clinical Studies
NEW YORK--As part of its growing effort to enhance the efficiency of government-funded healthcare research, Medidata Solutions recently worked with distinguished R&D and technical services institute RTI International to upgrade the technology it uses to provide statistical and data coordinating services for National Institutes of Health (NIH)-funded research. In recent years, a significantly growing share of this research has been conducted in support of biopharmaceutical development, prompting RTI to introduce new electronic data capture (EDC) and clinical data management (CDM) technology to best handle the unique data quality requirements of FDA-regulated studies.
•"RTI required the new EDC/CDM vendor to provide a software-as-a-service (SaaS) solution that could support rapid transition from existing study databases as well as a robust knowledge transfer program to ensure our complete self-sufficiency," said Rick Williams, senior research statistician, RTI International. "After extensive review of 20 systems, Medidata Solutions was selected and has met these requirements extremely well, along with providing the appropriate process and business support for government-funded research."
RTI is about to kick off its sixth study using Medidata Rave, with another three to four planned for the coming year. The majority of current studies support research sponsored by the National Institute of Child Health and Human Development (NICHD).
•"We're very satisfied with the smooth and rapid transition of our Pelvic Floor Disorders Network studies to Medidata's database," said Dennis Wallace, senior research statistician, RTI International. "The use of Rave has produced a high quality of data that conforms to regulatory requirements."
Medidata Rave is a fully hosted, web-based SaaS solution that is CFR 21 and Federal Information Systems Management Act (FISMA) compliant. Powerful, standards-based web services application programming interfaces (APIs) facilitate rapid integration to other systems to support advanced workflows, analysis, reporting and migration of data from existing clinical databases.
•"Government-funded research has become an important part of our business as the clinical data and study conduct standards for industry, government and academia converge," said Tarek Sherif, CEO, Medidata Solutions. "Our ability to support a prestigious organization such as RTI and the research networks it services is testament to our technical leadership in meeting those standards, as well as evidence of the ease in which government agencies can do business with us."
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About RTI International
RTI International is one of the world's leading research institutes, dedicated to improving the human condition by turning knowledge into practice. Their staff of more than 2,800 provides research and technical services to governments and businesses in more than 40 countries in the areas of health and pharmaceuticals, education and training, surveys and statistics, advanced technology, international development, economic and social policy, energy and the environment, and laboratory testing and chemical analysis. For more information, visit www.rti.org.
RTI International is a trade name of Research Triangle Institute.
About Medidata Solutions Worldwide
Medidata Solutions is a leading global provider of SaaS clinical development solutions that enhance the efficiency of customers' clinical trials. Medidata's advanced solutions lower 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.
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Source: Medidata Solutions
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