“I've conducted more than 200 audits over the past three decades. Many of them were 'for cause.'”
I wish I could tell you every one of those audits uncovered a unique problem, but I’d be lying. The details, organizations, and products changed but the excuses rarely did. After thirty years working in clinical research and quality management, I've heard the same explanations more times than I can count: “We didn’t have the budget. We were trying to meet an aggressive timeline. Our team was overwhelmed. We'll fix it after First Patient In. The CRO is difficult to work with.” And perhaps my personal favorite... “We don’t have the resources for nice-to-have initiatives, and quality is a nice-to-have.”
Every time I hear that last statement, I find myself thinking that quality isn't a nice-to-have initiative. It's the reason everything else succeeds! (… or fails.)
The Audit That Comes Too Late
A surprising number of the audits I've conducted weren't part of a carefully planned quality strategy. They were crisis responses. An important protocol deviation, unexpected inspection findings, data integrity concerns, incomplete TMFs, monitoring issues, vendor failures, suspected research misconduct, planned acquisitions… the list goes on. "Something" finally convinced leadership that it was time to understand what had been happening all along.
By then, it was too late. Instead of asking "What could go wrong?", the organization was asking "How could this happen?" That's an expensive question. Not because investigative audits are pricey, but because the opportunity to prevent the problem was long gone.
We've Always Done It This Way
"We've always done it this way" is one of the most dangerous phrases in clinical research. Sometimes spoken confidently and often with resignation, it quietly discourages curiosity, prevents processes from evolving, and normalizes risk. That’s when workarounds become standard operating procedures and people stop seeing risks for what they truly are. What was once viewed as a temporary compromise slowly becomes "the way we operate" until someone outside the organization asks a simple question: "Why?"
Then the paradigm shifts and everyone starts to panic, especially if the next sponsor audit or regulatory inspection is just around the corner.
The Hidden Cost of Waiting
One of the biggest misconceptions I encounter is the belief that investing in quality can wait until the organization has reached a particular milestone, size, or P&L target. Specifically, emerging biotechnology companies face tremendous pressure because funding is limited and teams are lean. Every dollar matters when you spend sleepless nights wondering about the next fund raise round, the next critical milestone, the impending acquisition... Under the pressure, leadership innocently resolves to strengthen quality later. In my experience, this thought process often leads to undetected problems, delayed study timelines, poor data quality, and questionable mid-study decisions.
Quality Protects Innovation
Over the years, I've supported many organizations preparing for regulatory inspections, mergers, acquisitions, and strategic investments. Many had built remarkable science and innovative therapies. Many had enlisted talented researchers and passionate, committed leadership. They believed their breakthrough technology would attract the investment needed to move into later-stage development.
But when the regulators, auditors and due diligence teams arrived, the questions weren't about the molecule, the device, or the tech. The questions were about the systems supporting them, the robustness of the study design, the reliability of data, the completeness of documentation, the thoroughness of oversight activities, and (you guessed it!) risk management.
I've watched promising organizations lose negotiating leverage because the reliability of the systems supporting their science came into question. I've also seen companies fail altogether, not because the innovation lacked potential but because they couldn't demonstrate that the data behind it could withstand regulatory scrutiny. The science wasn't the problem; the quality system was.
I challenge the idea that quality is a necessary evil. Quality protects the value of innovation. Without reliable systems, innovative ideas become difficult to defend. Without credible documentation, promising data becomes difficult to trust. Without effective oversight, regulatory confidence begins to erode. Quality doesn't compete with innovation, it enables it.
The Cost of Quality... and the Cost of Not Having It
Organizations frequently ask me how much it costs to implement a Quality Management System, strengthen their quality program, demonstrate supply chain oversight, or conduct a series of site audits. While I understand the root of their concerns, I respectfully submit they’re asking the wrong question. The question to ask is “What is the cost of not doing these things?”
The cost of not having quality can take many forms: closed clinical sites, delayed enrollment, increased number of monitoring visits, extensive and expensive CAPAs, data excluded from statistical analyses, and regulatory inspection observations, protocol amendments that could have been anticipated, missed trial milestones, delayed market entry, lost investor confidence, and lost acquisition opportunities. What’s worse is one difficult truth: The absence of quality deprives patients of the therapies they so desperately need.
Quality Is an Investment in the Future
ICH E6 (R3) encourages organizations to identify and address risks before they become findings. This approach is not only good regulatory guidance; it’s also good business strategy.
Organizations that invest early in quality spend less time reacting to crises, make stronger, defensible decisions and inspire greater confidence among regulators, partners, and investors. Most importantly, they preserve the value of the innovations they've worked so hard to create.
Quality isn't “the cost of doing business” or “overhead,” but rather an investment in the sustainability and profitability of the organization. Quality protects everything the business exists to achieve.
How Cedar and Stone Can Help
At Cedar and Stone, we've seen firsthand what happens when organizations wait too long to invest in quality and what's possible when they make quality a strategic priority.
Our experience spans more than three decades of clinical research and over 200 GXP audits across sponsors, CROs, Phase I units, vendors, and investigator sites. We help organizations build practical, scalable quality systems that support innovation rather than slow it down.
Whether you're preparing for your first clinical trial, implementing ICH E6(R3), strengthening vendor oversight, preparing for an acquisition, or responding to regulatory findings, we work alongside your team to build the governance, processes, and quality culture needed to protect both your data and your future.
Because the most expensive quality system is the one you build after the crisis has begun.