About the Episode
In our industry, we’ve seen regulators play a critical role in helping to pave the way for increased creativity in clinical trial designs. Yet, there are still questions on whether innovation and quality can truly coexist in clinical trials. This episode aims to tackle the "why" behind quality because the answer to this key question brings light to this important issue as clinical trial complexity continues to rise.
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.
VP, Commercial Operations
Kathleen Greenough, Vice President, Commercial Operations at 4G Clinical, has 16 years of experience in life sciences spanning Clinical Operations, Finance, and IT. Her wide range of solutions implementation expertise includes RTSM, CTMS, trial costing tools, OLAP financial suites and patient enrollment planning. Kathleen has also spent many years as a Clinical Financial Planner and Analyst at a major biotech in Cambridge, MA, gaining a broad and deep understanding of the challenges inherent in Clinical Development. Specializing in software adoption and a frequent speaker at industry conferences, Kathleen is most in her element when working within a user community to facilitate solutions that are insightful and truly helpful.
Laura Araujo has over 30 years of experience in Quality Assurance and Technology, holding various positions in Software Development, Quality Assurance, Software Auditing, and Technology Management. She has had positions in, or related to, the pharmaceutical industry for 25 years. Prior to joining 4G Clinical, for 10 years, Ms. Araujo was the President and owner of Ojuara, LLC, an independent consulting firm servicing the health care and pharmaceutical industries, as well as, technology development companies.