Culture of Quality Drives Superior Clinical Trials

Quality is a state of mind. No, this isn’t a serene Zen master talking from atop a hill in Tibet. It’s Sergey Nikitin, BSc, MBA, president and director of Prime Site Research Solutions Inc., speaking from the perspective of managing more than 500 trials across various disciplines and types of sites.

Communication and transparency are the drivers of quality, Nikitin says. “A culture of quality [thrives] when people know the office is open to communication, open to transparency, and there is an open field for everybody in the office to hear each other,” he explains.

Getting this right at the very outset is critical, Nikitin stresses. “There are a lot of [trial] stakeholders that come into play very quickly, and if we don’t have a [handle] on communication and transparency at [a professional] level, things start to suffer,” he says.

How to Create a Culture of Quality at a Research Site

Join Sergey Nikitin and Jessica Pinder of Prime Site Research Solutions at ACRP 2019 this April and learn how to create a culture of quality at your site. These expert presenters will share their experiences creating a culture of quality using an integrative approach in a team environment. They promise their techniques are easy to implement and include quality assurance checks, office guidelines, checklists, and more.

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However, maintaining a culture of quality is an ongoing journey, Nikitin cautions. “And it’s not about pointing fingers—it’s about finding ways to come together as a team” if a task isn’t being adequately addressed, he notes.

ACRP 2019

Leadership is key, but if it’s all one-way communication, it’s not going to work, he says. Instead, leverage communication and transparency to keep all team members engaged in the bigger picture.

People get inspired when they can see the full scope of the project and their own role within it, Nikitin says. “There’s that sense of teamwork that makes people pull together,” he adds.

Author: Michael Causey