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

Let’s talk adaptive trial design, particularly as it pertains to early clinical research right now.  Both large and small pharmaceutical companies see the potential to shorten development timelines using adaptive… Read more

For years, we relied on simple questionnaires to conduct trial feasibility: identify sites likely to enroll, send out a questionnaire along with inclusion/exclusion (I/E) criteria, and request each site to… Read more

The DaVita Clinical Research Health Economics and Outcomes Research team recently released a white paper on the changing health care reimbursement landscape with a particular focus on the role of… Read more