Sites Are Building Their Own Tech – SCRS On What That Means
By John Oncea, Chief Editor, Clinical Tech Leader
There’s a trend building in clinical research that reads differently depending on where you sit. Sites are increasingly investing in, building, and deploying their own technology to enable patients to conduct trial activity remotely rather than waiting for sponsors or CROs to hand them tools.
Some call it innovation; others call it frustration made operational. Jimmy Bechtel, Chief Site Success Officer at Society for Clinical Research Sites (SCRS), calls it both and thinks the industry should take both signals seriously.
“The frustration is real and data-backed,” Bechtel told me. “Eighty-two percent of sites experienced cost increases greater than 6% in 2024, over 40% struggle with salary competition, and 22% have lost money on digital solutions. When the technology you’re handed costs you time and money and doesn’t fit your workflow, building or buying your own starts to look rational, not rebellious.”
What BYOT Actually Costs Sites
The SCRS framework flags five core challenges sites face when bringing their own technology: cost analysis, internal usability, operationalization, sponsor usability, and validation. That’s a significant list, and it starts – in practice, Bechtel emphasized – at the money question.
“From what we’re hearing, the sequence tends to go: cost uncertainty first, then sponsor acceptance, then data portability and security concerns, and then validation and compliance,” he said. “Sixty-three percent of sites want better knowledge of technology costs – that’s a more immediate barrier than Part 11 for most.”
That sequencing matters because it pushes back on the common assumption that the regulatory compliance hurdle – specifically validation under 21 CFR Part 11 and GCP E6 R3 – is what stops sites from going the BYOT route. It doesn’t, at least not first. Sites that have figured out the financial picture and gotten sponsor buy-in then encounter compliance questions. “It’s not that regulation doesn’t matter – it matters a lot – but solving for it before you’ve addressed cost clarity and sponsor buy-in is getting ahead of where most sites actually are,” Bechtel said.
The sponsor acceptance piece is its own challenge. There are no shared minimum criteria today for what acceptable site-owned technology looks like. Bechtel described the landscape as early. “What does exist is a growing recognition – including from sponsors – that site technology capability matters,” he said. SCRS’s 2024 Global Landscape data ranked technology as the number three area that sponsors and CROs want sites to improve, framed specifically around knowledge of technology and the ability to conduct remote and technology-enabled trials.
The tension in that finding is worth naming: sponsors want sites to be more capable but haven’t yet defined what acceptable capability looks like when sites bring their own tools. “Closing that definitional gap,” Bechtel said, “is part of the work ahead.”
A Certification Problem In The Making
The SCRS framework’s long-term vision for BYOT includes industry-wide certification programs for site-owned technology, standards that would streamline sponsor acceptance and give sites a credible benchmark to point to. It’s ambitious, and Bechtel acknowledged it honestly.
“In a way, the Digital Innovation Initiative and the Site Technology Challenges and Solutions framework are expressions of that effort,” he said. “We’re working to define what ‘good’ looks like for site-owned technology – not to create a bureaucratic barrier, but to give sites a credible standard they can point to when seeking sponsor acceptance.”
Getting there requires a specific set of stakeholders at the table. Bechtel named regulatory bodies – FDA, EMA, the TGA – as essential participants, along with sponsors and CROs as the acceptance gatekeepers, and technology vendors who need to build toward emerging standards. Critically, he emphasized, sites themselves need to be there, saying, “They’re closest to the actual workflow requirements. SCRS’s role is to ensure the site voice doesn’t get drowned out by the larger commercial interests at that table.”
It’s a familiar problem with standard setting: the people with the most at stake operationally are often the least represented in the room where decisions get made. SCRS is trying to change that, and the Challenges and Solutions framework is one mechanism for doing so, translating site-level experience into language that can be used in industry conversations.
The Performance Signal Hiding In The Frustration
The most striking data point Bechtel shared in our conversation isn’t about what BYOT costs. It’s about what it produces.
“Sites that have embraced DCT solutions – including their own technology implementations – are seeing 160% more patients enrolled per site,” he said. “That’s not a protest. That’s a performance differentiator.”
That number reframes the BYOT conversation entirely. If the prevailing narrative is that sites adopting their own tech are doing so out of desperation – because sponsor-provided tools are too slow, too costly, too misaligned – the enrollment data tells a different story. Those same sites outperform the metric sponsors care most about.
“The frustration created the urgency, and the urgency is accelerating genuine innovation,” Bechtel said. “The industry should take both signals seriously.”
What taking both signals seriously looks like, in practice, is sponsors moving toward shared minimum criteria for site-owned technology rather than treating BYOT as an exception to be managed. Vendors building toward emerging standards rather than waiting for them to be handed down. Regulatory bodies engaging early enough to shape those standards rather than judging after the fact. And sites continuing to document their costs, their outcomes, and their workflow realities because that data is the foundation of every advocacy argument SCRS can make.
BYOT isn’t going away. Bechtel made that clear. “SCRS recognizes this and is focusing on supporting sites where they need it and gathering their voice to message how we can move forward collaboratively, in support of this eventuality.”
The question isn’t whether sites will own more of their technology stack. They already are. The question is whether the rest of the industry will build systems – standards, contracts, acceptance criteria – that meet that reality before it creates the next generation of problems.
Jimmy Bechtel is Chief Site Success Officer at the Society for Clinical Research Sites (SCRS). This is the second of two articles drawn from a recent conversation. The first examines SCRS’s work on integration, interoperability, and regulatory ambiguity in clinical trial technology.