Individuals perceive topics related to quality and how to establish quality within an organization in various ways. Several misconceptions prevail regarding what constitutes “quality” and a “quality program.” When designing a quality program, one must distinguish between quality, quality system, and compliance. These terms are used pervasively throughout the clinical research arena, and they are […]
Let's face it: clinical research coordinators (CRCs) can make or break any trial. Beginning with the site selection visit, the coordinator is carrying a large load. Tasked to learn new trial procedures, vendors, and schedules, they must also explain these details to patients and their team. Tight timelines and pressure from all sides wreak havoc […]
What inspired your interest in the field of regulatory science?
My experience as a clinical research professional greatly influenced my interest in regulatory science. With a background in human subjects protections and experience working on Phase II-IV drug studies, I developed an appreciation for how regulatory science impacts the development of new treatment options. Research […]
We’ll be the first ones to admit, we’ve had CRAs quit. They’ve even left PRA for other CROs. Sure, there’s the allure of new opportunities, new studies, new systems. But at PRA, we’ve noticed one big difference. They “boomerang” back. At a rate of 6.5 former employees per month, in fact. Believe us, we were […]
We are constantly exposed to technological advances in our personal and professional lives, from the latest gadgets to social media, and one of the biggest struggles is how to keep up with these advances. It can be a challenge to know how to use the newest “techy” versions and adjust to the workflows they change. […]