By Dennis Broyles, Sr. Director, Data Management & Clinical Strategist, CovarsaDx
There are common patterns with most clinical studies. Every sponsor—no matter the size of their company or the study indication—cares about the same three things: time, cost, and quality. The challenge is that those three priorities are often at odds. Everyone wants a study that moves quickly, stays on budget, and delivers defensible, high-quality data. But achieving all three only happens with design discipline.
At CovarsaDx, we believe that thoughtful study design isn’t a luxury, it’s the foundation of every successful trial. Whether it’s a respiratory diagnostic, a cardiac assay, or a point-of-care device, the work you do before the first subject is enrolled will shape everything that follows.
Balancing the Three-Legged Stool of Clinical Research
Sponsors and CROs both live under constant pressure. Timelines are tight, budgets are limited, and the expectations for quality are always present and only grow stricter with each regulatory update.
It’s easy to focus on the immediate goals of getting the study launched, recruiting fast, and generating data, but skipping over design fundamentals almost always costs more in the long run. A trial can only be as efficient as the strategy behind it.
Every decision—how endpoints are defined, which data are collected, how sites are chosen—adds weight to that three-legged stool. Push too hard on one leg, and the others give way. The key is balance, and that balance begins with a clear, realistic and achievable design.
Designing for Data Integrity
In my experience, many studies suffer not because they lack effort or resources, but because too much data is requested and collected, and then is of limited or no use. I’ve seen sponsors try to capture every possible data point, “just in case.” It’s an understandable instinct. After all, data feels like insurance. But when every data field becomes a “must-have,” efficiency, timelines and budgets are impacted.
Each unnecessary field creates downstream complexity. Data management workloads increase. Monitoring visits take longer. Queries multiply. The time and cost ripple effects are real, and they compound. More importantly, a bigger dataset doesn’t necessarily make a submission stronger. What matters to regulators is clarity, relevance, and data integrity.
Good design means being deliberate about what you collect, how you collect it, and why. Our teams help sponsors build that data strategy early, aligning study endpoints to the product’s intended use, regulatory pathway, protocol and study design, and the statistical plan. The goal is not just to complete a study, but to produce targeted, defensible evidence that supports a regulatory submission and stands up to audit scrutiny.
Quality and Ethics: The Non-Negotiables
There’s no shortcut to Good Clinical Practice (GCP). The two main tenets of GCP—human subject’s protection and data integrity—guide every decision I make with my team. No timeline or budget constraint can justify compromising either.
Clinical research, at its core, is about people. Every participant who volunteers for a study deserves protection, respect, and transparency. As CRO professionals, our responsibility is to ensure that ethical and regulatory standards aren’t just boxes to check but principles we live by.
That’s also why design discipline matters so much. A poorly designed study can unintentionally put participants at risk through unnecessary procedures, ambiguous protocols, or unclear inclusion criteria. Sound science and solid ethics are inseparable.
The Art and Challenge of Site Selection
If there’s one aspect of study planning that continues to pose challenges, it’s site selection. On paper, the process looks straightforward: evaluate potential sites, assess their patient populations, rank performance history, and select the top performers. In reality, it’s one of the hardest parts of clinical research.
I’ve seen highly rated sites underperform and “long-shot” sites become top enrollers. The truth is, every site operates under its own pressures of staffing, budgets, competing studies, and shifting patient demographics, and realistically no selection algorithm fully predicts success.
That’s where experience and agility come in. At CovarsaDx, we stay closely connected to our sites through our extended team and especially our dedicated CRAs who know the people behind the protocols—the coordinators, investigators, and staff driving each study forward. Those relationships give us the insight to spot challenges early, respond quickly, and help every site deliver with confidence.
Where Focus Becomes an Advantage
Scale isn’t everything. In fact, size can be a liability in clinical research. Large CROs are spread thin across countless therapeutic areas, often prioritizing high-revenue pharma projects. IVDs and medical devices don’t always get the same attention or the same level of expertise.
At CovarsaDx, our focus is targeted by design. We specialize in IVD and medical device studies, and that specialization pays off for sponsors. Our teams are responsive, our communication lines are short, and our leaders are hands-on. We bring both scientific expertise and operational flexibility, which means our sponsors get guidance that’s not just fast, but informed and defensible.
We’ve proven this model works. From pandemic-era respiratory studies to advanced molecular diagnostics, we’ve helped bring multiple products through FDA clearance and De Novo pathways. Behind each success is the same formula: experienced people, clear design, and disciplined execution.
A Smarter Way Forward
Every sponsor faces the same timeline, budget and quality considerations. But with the right partner, those considerations and choices don’t have to feel like compromises. A well-designed study delivers more than results. It delivers confidence.
As diagnostic and device development continues to accelerate, the CROs that stand out won’t be the ones chasing every project. They’ll be the ones who conduct studies with purpose and focus, and with ethics and data integrity at their core.
That’s the approach we take at CovarsaDx, and it’s what I’ve built my career on: thoughtful design, meaningful data, and a steadfast commitment to quality.
About the Author
Dennis Broyles, MSHS, RAC, CCRA, CCRP, is Senior Director of Data Management and Clinical Strategist at CovarsaDx. With more than 35 years of experience in in vitro diagnostics and clinical research, Dennis has led numerous IVD and medical device studies to successful completion and regulatory approval, including PMA, De Novo 510(k), 510(k), and EUA pathways. His expertise spans strategic planning, protocol development, clinical operations, and data management across diagnostic areas such as oncology, infectious disease, women’s health, and immunology.