Six Sigma Tools Offer Proven Clinical Trial Benefits

“Outside of the corporate world, the Six Sigma name can be intimidating, and it doesn’t have to be,” says Betsy Fallen, a consultant with BAFallen Consulting LLC, of the widely used set of techniques and tools for process improvement. “Six Sigma provides tools that you can use every day. You may be using these tools […]

Common Rule Compliance Confusion Could Pit Institutions Against Oversight Teams

By fits and starts, and not without a few bumps along the way, the Common Rule, a federal policy regarding human subjects protection that applies to 17 federal agencies and offices, including the U.S. Food and Drug Administration (FDA) and Department of Health and Human Services, went into effect January 22, 2019. The main elements […]

Medical Device Trial Leaders to Seek Research Professionals’ Input at ACRP 2019

Clinical trial professionals who’ve got ideas about how to better conduct medical device trials will have their opportunity to make a difference at the ACRP 2019 meeting in April in Nashville, Tenn., says Stephanie Christopher, MA, CCRC, FACRP, program director at the Medical Device Innovation Consortium (MDIC), a public-private partnership that focuses on regulatory science […]

It’s Time for Sponsors and Sites to Level with Each Other

“It’s an interesting dance we do, right?” That’s Jane Jacob, PhD, vice president for research and clinical affairs with Orthofix, on the sometimes-fractious relationship between sites and sponsors. “There’s a lot of misunderstanding on both sides,” she says, “but we have the same pain points,” such as budgeting, protocol development, and monitoring. “We’re supposed to […]