Robert Romanchuk, Schulman IRB Vice Chair

Don’t Let an FDA 483 Become an Intimidating Warning Letter

After visiting clinical trial sites for more than 10 years, Schulman IRB Vice Chair Robert Romanchuk has a simple message: When you get a Food and Drug Administration (FDA) 483, consider your response to it seriously. It’s your best opportunity to address the situation and get back to business. It sounds like common sense, Romanchuk […]

Michael Causey, ACRP Editor-In-Chief

Douglas Bryant: An Appreciation

Douglas Bryant loved life. You could hear it in his voice. Douglas Bryant loved helping people. You could see it in his actions. I had the good fortune to work closely with Douglas for the past year when, as part of his volunteer contributions as the Public Member of ACRP’s Board of Trustees, he joined […]

David Vulcano

Analyst: Trump Means Change for Clinical Research Industry

Donald Trump is scheduled to become the 45th President of the United States on January 20. There will be many indirect and direct impacts on our industry as a result. Broadly speaking, we’re looking at two kinds of change: What the Trump Administration will change, and what changes industry will make in response. For example, […]

White House

Clinical Research Industry Braces for Trump Impact

Pundits around the country and the world are scrambling to predict what to expect from a Donald Trump presidency. Critics have accused Trump of being light on details on many issues during the campaign, and that’s certainly the case with clinical trials, say some of the people we talked with shortly after the election. First, […]

John Neal, CEO of PCRS Network

Prediction: Mobile Devices to become Standard Means of Collecting Many Study Data Points

In the eight installment of this series of predictions, I addressed the impact of “remote visits” and predicted that as those increase the number of traditional onsite visits at clinical research sites will decrease. Technology is already facilitating remote visits, but there is much more to come as mobile data collection proliferates. "We are going […]