David Burrow

FDA Works to Remove Fear Factor from Inspections

The prospect of a U.S. Food and Drug Administration (FDA) inspection—much like a looming audit from the Internal Revenue Service—is extremely stressful for research site personnel. The good news? The FDA knows this and is making new efforts to reach out to industry to explain the positive side of inspections, says the agency’s David C. […]

Jim Kremidas, ACRP Executive Director

Standards Key to Preparing CRCs for Evolving Trials Landscape

While jobs are still plentiful today, clinical researcher coordinators (CRCs) must think about tomorrow, when the openings may begin to decrease even as the work becomes more complicated. With such innovations as remote monitoring and risk-based monitoring in place already or on the horizon, most experts agree that new demands on professionals will require new […]

Clarity, Communication Key to Informed Consent Efficiency

Layers of complexity can spark errors in informed consent documentation, slowing the process and even damaging clinical trials, says Lindsay McNair, MD, MPH, MSB, chief medical officer at WIRB-Copernicus Group in Princeton, N.J. Those engaged in informed consent policy and implementation should ensure the existence of clear descriptions of the eligible population and ought to […]

Ken Getz

Getz: Ideathon Winners Will Boost Clinical Trial Awareness

While a team calling itself C2: The Clinical Study Change Agent Collective from patient recruitment firm FCBVio was selected as the first “Inspiring Hope Ideathon” winner in a contest designed to spark creativity around raising awareness of clinical trials, program judges say they’ll connect the creators of the other project finalists and of several other […]

Carrie A. Hanger, an attorney with Smith Moore Leatherwood LLP

Sites Risk Heavy Fines Without Medicare Coverage Strategy

Clinical trial site leaders who lack a clear understanding of what is reimbursable under Medicare and Medicaid can face big fines and a big public relations black eye if they don’t develop a strong program, says Carrie A. Hanger, an attorney with Smith Moore Leatherwood LLP in Greensboro, N.C. While this tends to be a more common weakness […]