As clinical trials become more global, data-driven, and technologically complex, the systems that support them are under sharper regulatory scrutiny. Interactive Response Technology (IRT) is critical for randomization, drug supply management, and trial oversight. IRT is now a central focus of inspections across regions. According to industry observations, the number of IRT-related inspections has doubled since 2022, signaling a new era of vigilance from health authorities.

This rise reflects not only the sophistication of today’s trial designs but also regulators’ evolving approach: expanding the scope of inspections, increasing their frequency, and engaging directly with technology vendors as well as sponsors. For sponsors and providers, this raises the stakes. Inspection readiness is no longer a matter of last-minute preparation but of embedding quality into every layer of trial operations.

To unpack these changes, Drug and Device World sat down with Justine Koor, Director of Quality Assurance at IQVIA. Koor shares her perspective on the drivers of inspection growth, the challenges of global compliance, and the practical strategies organizations can adopt to stay ahead. She also looks to the future of quality assurance as regulatory expectations evolve alongside innovations in artificial intelligence (AI) and trial design.

The following interview has been edited for clarity, consistency, and length.

Phalguni Deswal [PD]: You have noted that inspections of IRT systems have doubled since 2022. What’s driving this surge?

Justine Koor [JK]: The growth in inspections is the result of several converging factors. First, we’re seeing more health authorities stepping into this space. Traditionally, inspections were concentrated in regions like the US and Europe, but now countries in Asia, including China, Korea, and Japan, are conducting their own IRT-related inspections. Each of these agencies brings its own approach and priorities, and together they significantly increase the overall number of inspections happening worldwide.

Second, the complexity of clinical trials has expanded dramatically. We’re dealing with adaptive trial designs, combination therapies, biologics, and digital endpoints, all of which demand robust systems to handle more nuanced data. The more complex the trial, the higher the risk, and regulators are keen to ensure those risks are being managed properly.

Finally, there’s been a cultural shift in the way inspections are conducted. Regulators no longer rely solely on sponsors for information. They want to engage directly with vendors, whether that’s IRT providers, electronic Clinical Outcome Assessment (eCOA) platforms, or other technology partners. By broadening the scope to include vendors, inspectors gain a clearer picture of how systems are built, validated, and maintained. That deeper dive naturally results in more inspection activity across the board.

PD: Different agencies have different inspection priorities. Where does this create the biggest challenge for sponsors?

JK: I think the main challenge lies in unpredictability, rather than in any specific regulatory difference. Each agency may emphasize slightly different areas. Some might drill deeper into system validation, others into audit trails or data handling, but if an organization is compliant, those differences don’t create fundamental vulnerabilities.

What does create pressure is the fact that inspections are difficult to plan for. They can arrive with little notice, and you never know how long they will last or which experts will be needed. Sponsors and vendors often have limited resources, so pulling people away from their regular responsibilities to support an inspection can be disruptive.

That’s why preparation is everything. Organizations must ensure that subject-matter experts are not only available but also confident in discussing their work. Compliance is not just about having the right processes on paper; it’s about being able to demonstrate them in practice, under scrutiny, at any time. That readiness is what allows companies to handle inspections from multiple agencies without being overwhelmed.

PD: You have described EMA’s guidance on computer systems as essential reading. Why is this document so important?

JK: The EMA’s guidance is valuable because it brings clarity and specificity to areas that were previously open to interpretation. For instance, it explicitly identifies IRT systems as “critical,” placing them alongside eCOA, electronic case report forms (eCRF), and other essential trial technologies. That designation leaves no ambiguity about the importance of IRT in the regulatory landscape.

It also reinforces best practices that were already known, such as the need for validation throughout a system’s lifecycle, from design to decommissioning, but adds detail on how to implement them. The guidance provides practical explanations of what constitutes an audit trail, how it should be maintained, and why regular review is non-negotiable. These are not new requirements, but the clarity helps organizations align their practices more consistently with expectations.

What I find most useful is that the guidance is widely referenced, not just within Europe but globally. Companies across regions use it as a benchmark. That shared framework helps harmonize practices, which is especially important when trials are multinational and systems are used across borders.

PD: What are the top strategies companies should adopt to prepare for inspections?

JK: “Be prepared” is easy to say, but harder to translate into day-to-day action. In my experience, three strategies are particularly effective.

First, design processes that people can actually follow. Too often, I see SOPs that are so complex or impractical that staff can’t realistically apply them in their daily work. That gap between policy and practice is exactly where non-compliance creeps in. Streamlined, practical processes reduce errors and improve inspection readiness.

Second, focus on education and culture. Compliance isn’t just about ticking boxes, it’s about understanding why the rules exist. When employees appreciate that procedures protect patients, ensure trial integrity, and ultimately safeguard public trust, they engage with compliance in a much more meaningful way. That cultural buy-in is invaluable when an inspector starts asking questions.

Third, prioritize documentation management. Having the right documents is not enough — they must be organized, clearly labeled, and quickly retrievable. During an inspection, fumbling through disorganized files can raise red flags, even if the underlying work was compliant. A well-structured document management system signals professionalism and preparedness.

PD: With clinical trials generating more data than ever, how can sponsors manage risk and data integrity?

JK: The first step is clear accountability. Contracts and agreements must explicitly state who is responsible for what. That way, when inspectors ask for documentation, there’s no confusion about who provides it. Lack of clarity in ownership is one of the quickest ways to create gaps during an inspection.

Beyond that, organizations need to think carefully about how they structure and store data. Some prefer a central repository; others use a distributed model. What matters is that the system is logical, consistent, and accessible to those who need it, especially quality assurance teams. QA should have at least read-only access so they can review and verify documentation on an ongoing basis.

Finally, I can’t emphasize enough the importance of internal audits and risk assessments. Data integrity isn’t a one-time achievement, it requires continuous vigilance. Regular checks allow organizations to spot patterns, identify deviations, and correct weaknesses before regulators do. That proactive approach is what separates organizations that are inspection-ready from those that are constantly playing catch-up.

PD: Looking ahead, how do you see quality assurance (QA) roles evolving in this environment?

JK: The essence of QA, ensuring compliance, safeguarding quality, and protecting patients, will remain constant. What’s changing is the context. The regulatory environment is evolving rapidly, particularly with the rise of AI, advanced analytics, and new data protection frameworks. QA teams must keep pace with these changes and adapt their oversight accordingly.

That means continuous learning is critical. QA professionals need to stay informed about new regulations, guidance documents, and technologies, and they need to ensure that knowledge is shared across the organization. QA cannot operate in a silo. Building a quality mindset across clinical operations, IT, data management, and vendor oversight is essential.

I also think we may see QA functions expand, both in size and in influence. As trials grow more complex, the need for quality oversight will only increase. Organizations that invest in strong QA teams will be better equipped to adapt to new requirements and to instill quality as a shared responsibility across all departments.

PD: What’s your key message for organizations facing more frequent inspections?

JK: My key message is: don’t be afraid of inspections. They’re not adversarial, they’re about protecting patients and ensuring trial integrity. If you build quality into your systems from the beginning, maintain compliance as a daily practice, and foster strong, transparent relationships with your partners, inspections become less of a hurdle and more of an opportunity.

It’s really a matter of perspective. Instead of dreading an inspection, view it as a chance to demonstrate the robustness of your processes and your commitment to doing the right thing. That mindset not only reduces stress but also builds confidence among inspectors, among sponsors, and within your own teams.