ACRP to Release First Ever Harmonized Core Competency Framework for Clinical Trial Monitors

Framework to Define Competence Requirements for Monitors/CRAs Working in Clinical Research

The Association of Clinical Research Professionals (ACRP) today announces plans to release a harmonized Core Competency Framework for Clinical Research Associates (CRAs) in December that for the first time ever will define the core competencies required of clinical trial monitors/CRAs within the […]

Digital Technology

Survey: Digital Tech Use Up in Clinical Trials, But Concerns Remain

Nearly 98% of clinical research professionals plan to use digital technologies to collect patient data within the next five years, according to a study of 166 biopharma and life sciences industry researchers, executives, and technology/software professionals conducted by Validic. Broadly speaking, the study’s findings highlight how digital technologies will become significantly more important in the […]

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 […]