DaVita Clinical Research Obtains USP 797 Compliance, Emphasizing Quality Standards at its Pharmacy
April 19 2011 - 9:00AM
Business Wire
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.
About DaVita
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
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