David Burrow, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Experts Ponder Tough Clinical Trial Challenges with Optimism

Unbowed by a litany of obstacles including the increasingly difficult path to finding new patients and an aversion to maximizing new technology, a quartet of industry thought-leaders exuded optimism about the future of the clinical trial industry during an engaging panel discussion Monday morning (April 15) at ACRP 2019 in Nashville. “We’re going to continue […]

Need Repair

Imagine a Paperless Site in Your Future

What’s keeping you from going paperless at your study site? Maybe it’s worries about the cost of transitioning to electronic source (eSource) documentation of your study data, or how long it will take. Maybe it’s the learning curve associated with a new system or apprehension about possible regulatory complications. Maybe it’s fear of technology or […]

Dr. Fred Johnson, CEO and Founder, InitiativeOne, Speaking at ACRP 2019

Successful Leaders Mine Inner Strengths

Ever feel inadequate at work? Like you aren’t up to the task of managing what’s happening today, much less what’s coming next? Here’s a newsflash: You aren’t the only one to feel that way, says Dr. Fred Johnson, chief executive officer and founder of InitiativeOne. He’s worked with Fortune 500 companies, professional and collegiate sports teams, […]

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 […]