Emmes Wins USD 70m National Institutes of Health Contract for Pediatric Research.
M2 PHARMA-August 3, 2017-Emmes Wins USD 70m National Institutes of Health Contract for Pediatric Research
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- US-based contract research organisation The Emmes Corp. has been awarded a contract from the National Institutes of Health to support pediatric clinical trials sponsored by the National Institute of Child Health and Human Development (NICHD), the company said.
Valued at nearly USD 70m, the 10-1/2 year contract will support the NIH's effort to improve the labeling of drugs for pediatric use.
The company's role as the data coordinating center involves study design, data management, regulatory support, pharmacovigilance, site monitoring, and statistical analyses.
The Best Pharmaceuticals for Children Act was enacted in 2002 and subsequently reauthorized by the Food and Drug Administration in 2007 and 2012.
One of its goals involves conducting clinical trials and research for on- and off-patent drug products meriting further study for children. NICHD activities are aimed at improving pediatric drug therapies through preclinical and clinical testing that lead to drug labeling change.
Most new drugs that have potential applications in pediatric care must be tested in children prior to receiving marketing approval in the US However, the majority of previously approved drug therapies have not been labeled specifically for children and are used off-label without adequate studies in children.
Emmes held the data coordinating centre role in the previous contract with the NICHD, which ran from 2009 to mid-2017.
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