Operationalizing ICH E6(R3) and QbD with a Quality Assurance Consultant

The updated ICH E6(R3) guideline makes explicit what has always defined high-performing clinical trial operations – proactive thinking, risk-based decision making, and quality that is designed into processes.

While the industry was first guided to implement Quality By Design (QbD) when ICH E8(R1) was released, ICH E6(R3)’s re-emphasis on term makes it clear that regulators are doubling down on QbD as a core expectation for clinical trial quality.

For many organizations, this shift is easier to agree with than to document and operationalize:

• Operational teams are already stretched thin.
• Functional silos make it challenging to embed quality into planning.
• Leaders support the concept of “quality by design” but don’t always have the tools, time, or cross-team alignment required to transform the culture.

This is where having a dedicated internal champion or external quality assurance consultant can become instrumental.

ICH E6(R3) Is a Mindset Change

R3 moves organizations away from reactive quality and firefighting towards proactive prevention. To make this shift stick, companies need:

Executive Sponsorship

Secure leadership commitment early and make quality a strategic priority. Executive sponsors should champion QbD by aligning it with business objectives, reinforcing it in cultural values, and ensuring resources and accountability are in place. Without visible leadership support, QbD becomes a siloed initiative instead of an organizational mindset.

Logical Simplicity

Start with the end in mind and keep it practical. QbD is built on logical principles-there’s no need to overcomplicate it. Instead of redesigning workflows from scratch, integrate QbD into existing systems. This approach minimizes disruption and sets teams up for success.

Simple Frameworks

Empower people with practical and intuitive approaches, not complexity. Implementing QbD doesn’t require elaborate technology or rigid systems. It requires clear, accessible frameworks that help teams focus on shared goals and apply quality principles effectively.

Inclusive Engagement

Leverage the expertise of the people closest to the work. QbD succeeds when organizations involve everyone, facilitating focused conversations, listening to frontline insights, and turning that knowledge into meaningful improvements. People are your most valuable asset in driving lasting change.

How can a quality assurance consultant help build a quality culture within an organization?

If a team does not have an independent internal champion deeply familiar with the quality tools and processes needed to facilitate and operationalize improved processes, bringing in an external quality consultant is often a helpful approach.

This clinical quality assurance consultant can support the following:

Help leaders become advocates for quality

A QA consultant can provide leadership with tools and coaching to champion transparency, objective measurement, and open communication.

Leaders must learn to model the ownership of quality across all levels – not just within QA. Additionally, a consultant can help executive teams align their quality goals with business objectives, ensuring that quality is seen as a strategic enabler, not a barrier. Leaders can also be coached and supported in their efforts to celebrate continuous improvement efforts and quality wins, reinforcing behaviors that support excellence, accountability, and innovation.

Lead risk-based and continuous improvement thinking across teams

QA consultants bring deep knowledge in risk management tools and methods. These can be used to help facilitate the early identification and mitigation of risks, embedding quality into planning (not just review).

Foster transparency and psychological safety

Leaders must eliminate cultures of blame or fear to provide a safe space for operational teams to share deviations and learn from mistakes without fear. This safety encourages open dialogue and continuous improvement.

Without an environment where teams feel safe to adopt new methods, share concerns, and trust that accountability will be shared, even well-designed process improvements stall.

Connect cross-functional stakeholders

A consultant can help teams bridge silos by aligning internal departments and vendors on shared goals, process improvements, hand-offs, and metrics. This alignment allows everyone to own quality outcomes that drive continuous improvement.

Promote education and ownership

Finally, QA consultants can empower teams through targeted training and coaching. This training helps individuals understand not just what to do, but why it matters. Understanding the “why” behind processes further drives a culture of ownership and excellence.

Conclusion

Whether you rely on an external QA consultant or tap into the strengths of your internal QA team, having a dedicated expert to guide the process can make ICH E6(R3) adoption and compliance far smoother.

The right partner can introduce practical tools, bring clarity to expectations, and connect teams around a shared approach to quality so that your organization can adopt new ways of working with confidence.

The PharPoint quality assurance team has deep experience within process improvement, risk management, and the needs of ICH E6(R3). To learn more about how our QA consultants can support your needs, reach out for an introduction.