What is “quality culture”?
Revised regulatory guidance from the last 5+ years has further clarified and re-emphasized the necessity of a culture shift in the industry that prioritizes quality beyond just checklists. Regulators and experts agree, inspection alone cannot guarantee quality. Specifically, in clinical research, audits and monitoring are important, but they should complement, not replace, a culture where quality is designed into processes and plans from the start.
ICH E8 R1 (adopted back in 2021), Sect. 3.3.1, Establishing a Culture that Supports Open Dialogue, states:
“Creating a culture that values and rewards critical thinking and open, proactive dialogue about what is critical to quality for a particular study or development programme, going beyond sole reliance on tools and checklists, is encouraged.”
This approach is a foundational shift that requires buy-in from study team members at all levels.
“Quality culture is a shared experience,” Melisa explains. “Ultimately, it means we behave in ways that continuously draw us closer, out of siloed thinking.”
She highlights that teams backed by a quality culture share a mindset of integrity in every action, always with patients in mind.
Both sponsors AND their vendors must have this quality culture in place.
When both sponsors and their CROs (and other study vendors) operate under a culture of quality, they’re able to form stronger relationships, communication pathways, and shared values – with a commitment to the rights and safety of patients and the integrity of study data above all else.
In practice, this might look the below example:
Sponsor A brought Vendor A into their risk management conversations early, identifying specific processes and areas of risk.
Together, they agreed on the key metrics that matter to the work and agreed on a shared dashboard which enabled informed discussions about signals ahead of issues. Together, they mapped the hand-offs, a discussion which led to a nuanced understanding of each team’s requirements.
Then, Sponsor A said, “listen if there is a problem – let’s get on the phone and get to the solution together.”
Over time, Vendor A saw they weren’t blamed for problems, instead they worked with Sponsor A to learn from each other and build long-term solutions, so the same problems didn’t recur. Vendor A sees Sponsor A as a partner. Sponsor A values Vendor A as an extension of themselves.
They keep getting better together.
However, when this is not true – when there is no quality culture or a quality culture mismatch exists (e.g., Sponsor has a quality culture but Vendor does not, or vice versa), frustrations and inefficiencies are given the opportunity to grow over time. This is why Deming warned against choosing partners based on cost alone, shared values reduce long-term risk and cost.
This might look something like:
Sponsor B considers the QA audit of Vendor A to be their proactive risk management. However, Vendor A is blind to risk factors critical to Sponsor B’s success.Problems arose early, such as delays and deviations. Each time an issue arose, Sponsor B grew more and more frustrated. For every new issue, a new check and approval was implemented on Vendor A’s work.
Feeling micromanaged, Vendor A stopped trying to collaborate with Sponsor B to solve long-term problems, instead responding to each e-mail and each comment begrudgingly. Vendor A becomes ambivalent about the quality of work they do for Sponsor B since they don’t feel like a valued partner. This causes bigger, more complex issues to arise.
Sponsor B ultimately gets so frustrated, they pull their business from Vendor A, delaying the project and devastating their budget.
