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
A common trend in the drug development industry is to utilize data and innovation to safely begin participant involvement earlier and earlier in clinical trials. As innovation continues to be… Read more
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For a company developing a new pharmaceutical or medical device product, what can a small contract research organization (CRO) offer? Why would anyone consider working with one, when preferred-provider arrangements… Read more
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