The Importance of Quality Assurance in Clinical Research: A Perspective from ARG
November 23, 2024 In the realm of clinical research, ensuring the highest level of quality and compliance is paramount. For Contract Research Organizations (CROs) like Atlantic Research Group (ARG), Quality Assurance (QA) is more than a department—it's a foundational element that supports every aspect of their work. Jennifer Stanislawski, Director of Quality Assurance at ARG, shares insights into the pivotal role QA plays in the success of clinical trials and the importance of maintaining rigorous standards.Experienced Quality Assurance Teams Impact Trials
Having been with ARG for nine years, Stanislawski's journey in the quality sector began with her role as a Quality Assurance Auditor, and she has since risen to the position of Director of Quality Assurance. Reflecting on her experience, she highlights the significance of quality assurance in clinical trials, saying, “We are part of the backbone of a company. We are ensuring patient safety from a compliance standpoint.” Her words emphasize how crucial QA is to the integrity of the research process, safeguarding both the participants and the resulting data.A Passion for Quality
Stanislawski's background is a testament to her dedication to quality. Her diverse work history expanded her passions. A self-proclaimed “lifelong learner,” Stanislawski says her aptitude for quality management was quickly recognized in a previous role.“I've always been personally interested in quality. When I worked as a medical technologist for a large pharmaceutical company, my lab group always put me in charge of dealing with our quality assurance department,” she explains, recalling how this passion eventually led her to pursue a master’s degree in regulatory affairs, further solidifying her expertise in the field.
What’s the Impact of QA Teams for Clinical Trials?
The primary role of QA in a CRO, as Stanislawski describes, is to interpret and apply regulations from agencies like the FDA and other global regulatory bodies. This ensures that every aspect of a clinical trial is conducted in compliance with the stringent standards required for drug and device approval.Getting ahead of non-compliance issues prevents costly delays, legal issues, and even trial termination. By proactively identifying and mitigating compliance issues through audits and inspections, a robust QA team like ARG’s helps streamline the approval process.
Central to this compliance effort is the process of auditing. An audit involves taking existing documentation and reviewing it to ensure accuracy. In clinical trials, documentation is crucial. Every action, observation, and result must be meticulously recorded to provide a comprehensive narrative to regulatory agencies. This documentation becomes the evidence that regulators rely on to understand what transpired during the clinical trial. This is especially vital for trials that take place over the course of several years.
“The only way the FDA knows what has happened throughout those five, ten years...is through the documentation,” Stanislawski says. “They interview people and talk to people, but the only way they truly can know is through what’s submitted.”
This underscores the critical role that QA plays in ensuring that all documentation is accurate, complete, and reflective of the actual events that took place during the trial. Without this, the integrity of the entire research process could be called into question, potentially delaying or even halting the approval of life-saving drugs and devices.
Quality Assurance also serves as a resource for Clinical Research Associates (CRAs) and other team members who might encounter issues during a trial. For example, if a CRA has a question about the informed consent process at a particular site, they can rely on their QA liaison for support. “We are there as a resource to be able to help them answer that question in real-time,” Stanislawski explains. This accessibility ensures that any compliance issues are addressed promptly, maintaining the integrity of the trial.
The Increasing Impact of Quality Assurance
With a long-standing commitment to ARG’s mission, Stanislawski has taken a journey from QA auditor to Director of Quality Assurance that mirrors the company’s own development, demonstrating how quality assurance has become increasingly critical in an industry that demands nothing short of excellence.“I’ve been in the director role for about five years. It’s the 20th anniversary, and I started back when it was our 15th,” she shares, reflecting on her own growth with the company and the evolution of QA as an integral part of the organization.
The role of Quality Assurance in clinical research cannot be overstated. It is the cornerstone that supports compliance, ensures patient safety, and upholds the integrity of the data collected. For companies like ARG, having a dedicated QA team led by experienced professionals like Jennifer Stanislawski is essential to navigating the complex regulatory landscape and ultimately bringing safe and effective therapies to market.
