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