Naila Ganatra

Competency-Based Training: Why Does It Matter?


What are competencies?

While the concept of competency development has been around for quite some time (R.H. White, 1959), it has increasingly come into focus in clinical research as clinical trials continue to become more complex. Competencies can be defined as a set of related skills, knowledge, and abilities that enable individuals […]

Jim Kremidas, ACRP Executive Director

Present-Day Clinical Trial Landscape

It is one thing to recognize the potential benefits of a technology, but it’s another thing entirely to become comfortable enough to use it with any frequency. That’s where we find many clinical trial professionals today. Read More Source: Pharma Tech Outlook

Dr. Scott Gottlieb, FDA Commissioner of Food and Drugs

FDA Updates Expansive Opioid Abuse Battleplan

In an effort to “forcefully” address the opioid abuse health crisis across the nation, U.S. Food and Drug Commissioner Scott Gottlieb, MD, recently offered a comprehensive update on its various initiatives. “I don’t want to look back 10 years from now and wish there were more policies we had pursued, or more steps we […]

Managing Real-World Patient Data Can Improve Trial Design

Properly identified and managed, real-world data (RWD) can streamline trial design and improve execution to save time and money, says Michel Denarie, a senior principal with IQVIA’s Strategic Drug Development team, a group that helps sponsors with their early clinical development strategy. Patient data represent an overlooked source of valuable information, Denarie says. “Clinical trial […]