The Why Behind Quality

Welcome to Trial Trends™, a monthly podcast brought to you by 4G Clinical and hosted by Kathleen Greenough, Senior Director of Client Solutions at 4G. Here, we tackle big ideas, challenge the status quo and bring new perspectives to the rapidly changing world of clinical trials. Get ready to disrupt the old ways of thinking and discover the newest trial trends!

There is a misconception in our industry that quality regulations can stifle innovation. For today’s episode, Kathleen is joined by colleague Laura Araujo, President of Quality at 4G, to tackle the why behind quality. As the conversation kicks off, Laura shares her own career background, which began as a developer in the department of defense after she earned her undergraduate degree. She quickly began to question the rigorous schedule and guidelines of the department, and transitioned over to software quality. From there, she found her way into the pharmaceutical industry and has remained there ever since.

Generally, quality departments are perceived as the major enforcers of regulations in the industry. Laura believes this misconception is largely based on the fact that people are so dedicated to complying with regulations that they assume quality is solely responsible for ensuring compliance. The primary reason for regulations is to protect subjects in human clinical trials. Quality is aware of this, and simply aims to keep everybody safe.

Laura stresses that quality is not an enforcer, but rather a teacher. It is crucial for people to understand the why behind quality, as it gives them the motivation to follow the processes in place. Quality is a department of continuous improvement and evolution. The goal of quality is to get people to think in terms of process and instill quality as a permanent mindset of the industry

To convince someone that partnering with quality is the best way, Laura would urge them to give it a try before writing it off completely. Many people believe having a process in place will only slow them down or decrease creativity. To these people, Laura recommends they begin asking questions about the process and its function over time. In the interest of new employees, it’s crucial to ensure those in leadership positions understand the quality so they may accurately pass it down to other employees. Finally, she stresses that quality culture is a mindset, not a hindrance. In fact, innovation is helped when these guidelines are always at the forefront of your mind when coming up with new ideas.