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.”
Connect with Medidata:
- Read our blog, Geeks Talk Clinical
- Tweet this: .@RTI_Intl selects @Medidata Rave to tackle FDA-regulated #clinical trials. http://bit.ly/GUaTqn
- Follow us on Twitter: @Medidata
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