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NIH ‘All of Us’ Program Funds Three New Genome Centers

The National Institutes of Health’s (NIH’s) All of Us Research Program has awarded $28.6 million to establish three genome centers around the country. These centers will begin to generate genomic data from biosamples contributed by program participants. Ultimately, this information will become a critical component in the program’s precision medicine research platform, a national […]

FDA Commissioner Scott Gottlieb, MD

FDA Continues Proactive Clinical Trial Guidance Rollout

President Donald Trump, an avowed promoter of limited government, might be a bit surprised by the activities of U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD. Leading a seemingly reinvigorated FDA, Gottlieb’s agency continues to issue proactive guidances at an impressive pace. To be sure, not every guidance expands federal oversight, yet most […]

Rashieda Gluck, Senior Vice President for Global Clinical Operations, Aurinia Pharmaceuticals

To Attract the Best Study Sites, Treat Them Like ‘Real’ Partners

Sponsors and contract research organizations (CROs) hoping to retain high-quality sites for their important clinical trials should treat site personnel like partners by supporting them throughout the lifecycle of the studies, says Rashieda Gluck, senior vice president for global clinical operations at Aurinia Pharmaceuticals, a 40-employee shop that works across more than 200 clinical trial […]

David Vulcano headshot

Advanced Communication Skills Help Sponsors, CROs Attract Best Sites

Sponsors and contract research organizations (CROs) hoping to stand out in the crowd and attract the "best of the best" sites would be well advised to keep the lines of communication wide open before, during, and after a clinical trial. “Some studies have provided us with FAQ spreadsheets--the spreadsheets where they track questions regarding the […]