Patient enrollment for clinical trials can be a challenging task especially if the patients are dealing with a chronic illness. Dialysis patients in particular are a population that need a… Read more

Over the next few years, the patents for many therapeutic biologics will expire, allowing drug manufacturers to request US Food and Drug Administration (FDA) approval for biosimilars, medical products which… Read more

New study sheds light on the factors for high turnover of principal investigators in FDA-regulated clinical trials. The U.S. biopharmaceutical industry is a global leader in the development of innovative… Read more

Sometimes you experience great service. An interaction that leaves you thinking – WOW, that person really loves their job! A problem you had solved in a way that left you… Read more

Informed consent to participation in a clinical trial involves substantially more than obtaining signatures from subjects on a written form. It includes providing to potential participants enough information about the… Read more

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By Amy Young, VP and General Manager, DaVita Clinical Research Drug development is expensive and complicated. Those facts seem to ring more true each year. According to the Tufts Center… Read more

Getting people with Chronic Kidney Disease (CKD) in on the ground floor. At DaVita Clinical Research, our specialty is performing research in people with chronic kidney disease (CKD). From the… Read more

 The study case report form (CRF) is arguably the most important clinical study document. While the protocol drives the conduct of the study, the CRF dictates the data to be… Read more

Since 2008, there has been an exemption to specific regulatory CGMP requirements for certain phase 1 clinical trial supplies, including active pharmaceutical ingredients.  Do you know if your next project… Read more