As we continue our celebration of World Quality Week, we’re excited to spotlight one of the talented team members who drives Profound Research’s commitment to excellence, innovation, and compassion in clinical research—Sarah Darnell, Validation Engineer at Profound Research. Sarah is an experienced Validation Analyst with a robust background in the pharmaceutical industry, bringing expertise in FDA regulations, Electronic Data Capture (EDC), and clinical research. With a Bachelor’s in Psychology from Texas State University, Sarah’s unique perspective and skill set empower her to elevate Profound’s mission of "Improving lives by providing advanced therapeutic options."
What motivated you to pursue a career focused on quality in clinical trials?
Sarah: “In my past careers, quality departments were often viewed as a roadblock to business operations. Coming from the business/site side of clinical operations, I am dedicated to changing that narrative and upholding strong ethical standards in conducting clinical trials. Being part of the quality team at Profound allows me to be innovative. Our team has been integral in shifting the stigma, showing that we’re here to foster an environment of continuous improvement and innovation—not to make anyone's job harder. We are partners in making trials more effective and ethical.”
Profound Research’s commitment to "Creating the absolute best patient-physician experience in clinical research" shines through Sarah’s dedication to not just maintaining, but improving quality standards, building trust with her colleagues and fostering a collaborative atmosphere that drives true progress.
Describe your role on the Profound Research Quality Team.
Sarah: “The primary focus of my role is to ensure that electronic systems are properly qualified and validated. This is essential for regulatory compliance and the integrity of the data we handle. During the implementation of an electronic system, we test business processes to identify and mitigate risks early, ensuring trials run smoothly and adhere to the highest quality standards. Quality systems validation is fundamental in preserving the integrity of data collected throughout a clinical trial, contributing directly to the efficacy of new treatments and improving patient lives.”
In her work, Sarah embodies Profound’s values, particularly Excellence and Urgency. By swiftly identifying potential risks and creating high-quality validation processes, she ensures that every data point gathered is reliable and contributes to the company’s mission to improve lives.
In your role, how do you ensure quality and consistency across multiple sites in a nationwide network like Profound Research?
Sarah: “Ensuring quality and consistency across all Profound sites is the cornerstone of quality systems validation. To support a nationwide network, validation provides the assurance that our electronic systems not only meet the operational needs of our sites but also perform consistently for our end users. We achieve this by creating clearly defined, standardized processes so that every site in our network can consistently execute clinical trial activities and deliver high-quality data nationwide.”
Profound’s values of Solution Orientation and Compassion are evident in Sarah’s approach to supporting consistency across a diverse network of sites. She is focused on delivering efficient solutions and maintaining the integrity of data, which is crucial to patient outcomes and the trust of healthcare professionals.
What do you enjoy most about working as a member of the Quality Team at Profound Research?
Sarah: “Being part of the quality team at Profound allows me to make a tangible difference in the patient’s experience in clinical trials. Problem-solving and improving processes has always been a passion of mine. It’s exciting to apply this passion to advance Profound’s mission. Every improvement we make brings us one step closer to our vision of creating the absolute best patient-physician experience in clinical research.”
Sarah’s dedication to Compassion drives her work, aligning with Profound Research’s vision. Her commitment to making a positive impact on the patient experience strengthens the bond between patient and physician, while her focus on innovation ensures that Profound continuously enhances clinical trial processes for all involved.
Can you share an example of a challenge that led to a triumph—an experience where you faced difficulty while maintaining Profound’s high standards for quality?
Sarah: “Validating and implementing electronic systems has been my greatest challenge. Profound has a diverse group of employees with extensive experience in the clinical trial landscape. Collaborating with these experts presents varied perspectives, which can sometimes lead to differences of opinion. However, through collaboration, we’ve been able to turn those varied perspectives into opportunities for innovation. Together, we’ve developed high-quality processes that elevate our standards even further.”
Tell us something fun or unique about yourself.
Sarah: “My parents used to own a small-town restaurant in Aransas Pass, Texas. I started working for them when I was in the 4th grade; my aunt taught me how to count back change, and since I was the only employee not stealing money, I ended up as the head cashier. It taught me responsibility early on and gave me a unique start in understanding the value of integrity.”
Sarah’s journey to Profound Research has been filled with valuable lessons and unique experiences that have shaped her into the passionate and skilled professional she is today. Her commitment to excellence, compassion, and continuous improvement truly reflects the values at the heart of Profound Research. We’re thrilled to have Sarah on our team, driving forward our shared mission of improving lives by setting new standards for quality in clinical trials.
