DaVita Clinical Research® (DCR®), a provider of clinical research services focused on kidney research as well as a multitude of specialty therapeutic populations, announces the completion of its Phase I-IIa Clean Room to comply with USP 797 high risk regulations. In establishing this distinction, DCR has demonstrated its Clean Room abides by the requirements set in place for the USP 797 high risk compliance and ensures its ability to handle compounds in a safe and efficient manner.
With more than 20 years of experience in early clinical studies in renal research, DCR performs a vast number of clinical trials each year. Operating under USP 797, DCR emphasizes the importance of meeting quality standards to maintain, components and environments for sterile compounding preparations. In addition to its hospital co-located facility; on-site, state-licensed pharmacy; 8,000 patient database; and complex study focus, DCR now adds its USP 797 compliant clean room to its list of tools that distinguish the company as a renal industry leader.
“The purpose of the clean room and the USP 797 guidelines is to reduce infection risks to patients where compound sterile preparations are prepared, as well as to protect pharmacy staff,” stated DCR Vice President of Clinical Services Amy Young. “Many clinical facilities are struggling to fully comply with this regulation. We are dedicated to delivering superior clinical results. The achievement of the USP 797 standard demonstrates this dedication and DCR’s commitment to our patients.”
With a staff that is fully committed to advancing the knowledge and practice of kidney care, DCR brings unsurpassed knowledge, skill and expertise to pharmaceutical research, helping ensure the success of clinical trials.
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About DaVita Clinical Research
DaVita Clinical Research (DCR) is committed to advancing the knowledge and practice of kidney care. DCR brings unsurpassed knowledge, skill, and expertise to pharmaceutical research, ensuring the success of their clients’ clinical trials. DCR’s clinical expertise ranges from designing the study to preparing and submitting the final report. DCR’s Early Clinical Research unit (Phase I-IIa) and Clinical Development network of physicians and investigative sites, Health Economics and Central Laboratory are focused on providing world-class clinical research in both complex/specialty populations and therapeutic areas as well as CKD and ESRD populations needed to meet clinical goals. To learn more about DCR, visit www.davitaclinicalresearch.com.
DaVita Inc., a Fortune 500® company, is a leading provider of kidney care in the United States, delivering dialysis services and education to patients with chronic kidney failure and end stage renal disease. As of December 31, 2010, DaVita operated or provided administrative services at 1,612 dialysis facilities, serving approximately 125,000 patients. DaVita develops, participates in and donates to numerous programs dedicated to transforming communities and creating positive, sustainable change for children, families and our environment. The company’s leadership development initiatives and corporate social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu, among others. For more information, please visit www.davita.com