Risk Management Has its Role in Device Development, Too

Many clinical researchers are familiar with the concept of risk management in drug development, but not so familiar with the role it plays in medical device development—especially long before a device even reaches the clinical trial stage. Walking their audience at an ACRP 2019 session in Nashville through the complexities of “A Five Step Approach […]

Denise Snyder, MS, RD, LDN, Associate Dean for Clinical Research at Duke

Thinking Ahead Key to Launching a Major Research Management System

Feeling like a challenge? How about implementing an enterprise-wide clinical research management system in an already-complex research environment at a major academic medical center? One simply does not launch into such a project without careful planning, according to two presenters in a session at the ACRP 2019 gathering in Nashville who have lived through the […]

Melissa Bolton

Getting Multicenter Studies Under Control with Technology

It’s all well and good for drug and device companies or contract research organizations to temporarily share technology with study sites that will keep externally sponsored trials running efficiently, but what happens when an investigator based at a site with limited tech capabilities of its own is acting as the sponsor? Worse yet, what happens […]

Eric Pittman, FDA

FDA Official Offers Valuable Inspection Tips

There was some good news and some bad news to be had at a crowded morning session with Eric Pittman, FDA, Program Division Director, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs at the ACRP 2019 Conference in Nashville today (April 13). The good news? More than half of attendees said they felt “very” […]

Harvey Yau, Senior Director for Scientific Product Development, Kelly Services

Can Clinical Research Professionals Thrive in the Gig Economy?

“When your work is quite literally life-changing,” the importance of matching your talents as a clinical research professional to the right employers reaches new heights in the environment of today’s “gig economy…and free style of work,” says Harvey Yau, senior director for scientific product development with Kelly Services, an office staffing company. Speaking on Friday […]