Blog Post
One Simple Change to Benefit Sites
The problem with staying comfortable
What staying on paper is costing us
Not all hassle is created equal
So, how do we change?
Catherine Gregor speaking at the 2025 Innovation Network Gathering in Pennsylvania.
There’s a saying that gets thrown around in clinical research so often it’s almost become wallpaper: if it isn’t written down, it didn’t happen.
It sounds simple. Logical, even. We work in an industry built on evidence, and documentation is how we generate and maintain that evidence. But when Catherine Gregor, Chief Clinical Trials Officer at Florence Healthcare, opened her ING 2025 keynote with that phrase, she wasn’t endorsing it. She was using it to unpack something the industry rarely says out loud.
For too long, “write it down” has meant paper, and paper has quietly become one of the biggest obstacles standing between clinical research and the patients who need its outcomes the most.
The Problem With Staying Comfortable
In the first 20 years of her career at clinical trial research sites, Catherine worked across almost every site role. That experience gives her a perspective that most leaders in the industry don’t have: she knows what it actually feels like to balance protocols and patients against a backdrop of constant chaos.
Which is why she’s skeptical when people write off sites as technophobic.
Sites aren’t actually afraid of technology, they’re afraid of the hassle that comes with technology.
Catherine states, “In our rush to go digital, we stacked tech on top of sites like Jenga blocks. And now we stand here and wonder why they feel so fragile.” Today, the average sponsor study comes packaged with five mandated, separate systems. The problem isn’t resistance to change, it’s that the industry has placed a bigger burden on sites by requiring their use of technology that may or may not actually support the work done at the site level.
The result? 85% of the global site market still captures data on paper. Not because they’re technophobic, but because they’re exhausted, and paper seems like the most consistent option.
What Staying On Paper Is Costing Us
To illustrate what’s actually at stake, she shared a story from her own career: A small biotech company was working on a Phase I trial for triple negative breast cancer. The outcomes were promising but in an effort to cut operational costs, they opted out of EDCs and chose carbon paper based record keeping.
For the next five years, the study accumulated data captured by multiple clinical ops staff, private investigators and more. The records became fragile, often illegible, and increasingly incomplete.
When the FDA conducted their audit, the documentation couldn’t withstand regulatory scrutiny. The drug wasn’t approved on the initial submission and the sponsor was required to re-monitor all of their study data, a process that delayed the drug’s approval by 18 months.
Catherine goes on to say,”That’s not just a delay. That’s a lifetime. That is the entire life expectancy of a woman newly diagnosed with metastatic disease.”
The drug eventually was approved. It went on to help thousands of patients. But it raises the question, “How many lives were shorter than they could have been because the industry clung to pen and paper?
Not All Hassle Is Created Equal
Clinical trials don’t have to operate this way. We have to be willing to confront the realities of technology adoption – both at the site and sponsor level – and embrace change for the sake of our patients’ lives.
For example, embracing change doesn’t look like logging into five disconnected systems to enter duplicative data. It looks like implementing data standards that unify records across a study portfolio, which allows sites to move faster and get treatments to patients sooner.
The clinical research community has navigated this before. When Electronic Health Records were first introduced roughly 25 years ago, pushback was universal. It highlighted a massive learning curve that felt uncomfortable for many.
In contrast to today, 82% of physicians say they make better decisions because of EHRs and 92% say they’ve experienced improved communication. As a result, more than 60 million Americans have received more coordinated care because of them.
Ask yourself: Which of the “burdens” your site or organization resists right now can lead to a better outcome for efficiency and overall patient outcomes?
So, How Do We Change?
More often than not, when we talk about change, the conversation is centered around the amount of burden placed on sites. But the burden isn’t caused by asking sites to change, the burden is the result of staying stuck in a system that no longer works: fragmented tools, disconnected data, and paper records that can’t integrate or scale.
Change isn’t just happening, it’s already here. For Sites and Sponsors alike, the choice now lies in leading that change intentionally, or getting caught scrambling to catch up. The FDA is actively advocating for digital record-keeping and global regulatory authorities have aligned on audibility and data standards. Waiting for digital to become mandatory means losing the window to do it well.
But there’s a deeper shift underway that determines who the leaders will be while these changes are taking place. Florence’s 2026 State of Clinical Trial Technology Report surveyed over 400 sites, sponsors, and CROs to understand how 2025 trends revealed an inflection point in the industry. AI is amplifying the impact of technology at organizations with digitally connected workflows, while simultaneously widening the gap for those that haven’t yet crossed the chasm. The report identifies 5 strategic imperatives for 2026 and how sites and sponsors can position themselves to stay ahead of changing digital infrastructures. Download the report.
