From Compliance to Collaboration: How QA is Shaping the Future at Panthera
By Steve Scull, Associate Director of Quality Assurance
When people hear “Quality Assurance,” they often think of audits, checklists, and paperwork. And while those things still matter, QA today looks very different, especially here at Panthera. Over the last few years, our role has evolved from being primarily compliance-focused to becoming a trusted partner in driving innovation and improvement across the business. But how do we do that while remaining true to the purpose of QA?
Moving from Reactive to Proactive
The latest updates to ICH GCP E6(R3) place a much greater emphasis on risk-based quality management. In practice, that means we’re not just ticking boxes after the fact. Instead, we’re actively looking ahead, anticipating risks, and making smart decisions before issues arise.
Within Panthera, QA, our focus is on building systems, processes, and awareness that support smarter decision-making before problems arise. We’re increasing our visibility and influence throughout the delivery phase, helping to create a culture where quality is proactive, not an afterthought.
Embracing the Digital Shift
It’s no surprise that technology is transforming every part of the clinical trial process, and QA is no exception. New systems bring efficiency and flexibility but they also raise important questions around validation, data integrity and regulatory compliance.
We are currently preparing to implement a new eSource platform across Panthera sites. This system will modernise how we capture and manage source data, enhancing consistency and reducing administrative burden. QA has actively been involved in readiness activities, ensuring the platform is appropriately validated and that our processes align with GCP and regulatory expectations. It’s a pivotal move forward and compliance will be a foundational part of the transition.
Creating a Culture of Quality
In my 13 years in clinical research, and over three at Panthera, I’ve learned that quality doesn’t come from systems alone. It comes from people. It’s something you must embed into the culture of an organisation.
That’s why I launched the Panthera Quality Culture Roadshow: a series of in-person sessions delivered at every site. The aim was simple: make quality real and relatable for every team member, not just those with “QA” in their job title.
It wasn’t easy at first. But by starting at the top and securing senior leadership support, we have been able to create a genuine ripple effect across the company. Today, quality is something everyone owns and champions in their day-to-day work.
Growing the QA Team
When I joined Panthera, I was the company’s first dedicated QA employee. There was no formal Quality Management System, no internal audit function, and no team in place. Since then, we’ve built the QA function from the ground up, designing and implementing a robust QMS, recruiting experienced professionals, and developing clear quality frameworks that support compliance across all sites. I’m currently mentoring one of our QA Coordinators into an auditing role, a clear example of how we’re nurturing talent and building future capability from within.
Looking Ahead
The clinical trials landscape is evolving fast. Trials are more complex, more digital, and more focused on the patient than ever before and QA must evolve in parallel.
Our goal at Panthera isn’t just to ‘keep up’. It’s to lead. QA is now embedded in how we deliver high-quality, reliable research. We’re strategic partners, supporting smart, risk-based decisions, adopt new technologies, and fostering a culture where quality is everyone’s responsibility.
Ultimately, the role of QA is to ensure that what we deliver isn’t just compliant, it’s credible, consistent and trustworthy. And that trust is what leads to better outcomes for patients, for sponsors, and for the future of clinical research.