Paving The Way For Sites To Use Their Own Tech
By Dan Schell, Chief Editor, Clinical Leader
We all know that for years, clinical research sites have been buried under a mountain of technology, most of it not their own. In many sponsor-led trials, sites are handed a grab bag of tech tools and told to adapt. But with some sites now managing up to 22 systems per study (I was shocked to see this stat!), burnout, errors, and inefficiencies are predictable outcomes.
The Decentralized Trials & Research Alliance (DTRA) just released a detailed “Bring Your Own Technology” (BYOT) playbook meant to flip that model on its head. It lays out a framework that allows sites to use their own validated tech — such as eConsent systems — in industry-sponsored trials. It’s a serious shift with a simple premise: If a site is already using compliant, effective tools, why force them to abandon those systems for something less familiar?
The BYOT initiative is part digital reform and part culture change. It recognizes a reality many in the industry have avoided: site operations have matured, and many are fully capable of selecting and managing compliant tech.
“DTRA stepped in because no one else would,” says Joe Dustin, one of the playbook’s architects, a consultant with Dauntless eClinical Strategies, and just a guy who seems to know everyone in the industry. “Vendors won’t do it, industry groups weren’t set up for it, and sites have been stuck in the middle. BYOT is our attempt to bridge that gap between sponsors and sites.”
WHY THIS, WHY NOW?
The push for BYOT gained urgency during the pandemic, when remote monitoring became mandatory and many sites had to quickly digitize their workflows. As Dustin notes, “When COVID happened, sponsors needed remote access, and sites had to figure it out — fast. That kicked off a technology transformation that’s still underway.”
With many sites investing in platforms like eConsent, eISF, and eSource, the question became: How do you incorporate these site-owned systems into sponsor-led trials without sacrificing oversight or compliance?
The playbook answers that question, offering a path for sponsors to say “yes” to site-owned tech — at least in phases. Horizon 1 focuses on eConsent, seen as the lowest-risk use case. Future phases will address more complex systems like eSource and direct data capture.
But let’s be clear: BYOT isn’t about replacing sponsor systems entirely. It’s about introducing flexibility. Sponsors can still provide technology to sites that need it. For those with robust, compliant systems already in place, BYOT gives them the option to keep using what works.
THE FIRST STEP IS JUST GETTING THE ‘YES’
In its first iteration, BYOT still involves compromises. A site might be allowed to use its preferred eConsent platform, for example, but still must manually enter consent metadata into the sponsor’s EDC system. “The first step is just getting the ‘yes’ from the sponsor,” says Dustin. “Once that’s in place, we can start working on the integration.”
That integration will take time. One of the biggest hurdles is standardization — particularly around data formats and interoperability. Sponsors want clean, consistent data. Sites want autonomy. The middle ground? A “compliance dossier,” a standardized package of validation and documentation that sites can submit to sponsors to demonstrate their tech meets regulatory standards like 21 CFR Part 11 and ICH E6(R3).
Some larger sites and academic institutions already have compliance teams or IT staff who can handle this. Smaller sites may struggle. “Eventually, we’ll need some kind of industry seal of approval — ‘BYOT certified’ — so sponsors can trust these systems without revalidating every single one,” Dustin says.
He likens the current phase to quality management roles: the job isn’t one-and-done. Dossiers need to be maintained and systems regularly updated. It’s not just an onboarding exercise — it’s a new ongoing responsibility for sites that choose to go this route.
WILL SPONSORS ACTUALLY GO FOR IT?
Not all will, at least not immediately. Some pharma companies, especially those in highly competitive enrollment spaces like diabetes or heart disease, may be more open to flexibility if it helps them win over high-performing sites. Others will continue to prioritize central control.
“In a lot of cases, sponsors say no just because they don’t know how to say yes,” Dustin points out. The playbook is designed to eliminate that excuse — to provide a vetted, structured process for making BYOT work.
Still, there are tradeoffs. For sites, BYOT could reduce training time, increase staff efficiency, and improve participant retention. But it also means owning more of the tech infrastructure and validation burden. For sponsors, it may lower costs and improve data quality — eventually. But in the short term, oversight becomes more complicated, and data standardization takes a hit.
JUST THE BEGINNING
The playbook isn’t a final answer; it’s a beginning, a living document that will evolve through pilot studies and real-world feedback. GSK already has started using a standardized assessment tool to evaluate site-owned eConsent systems. Other sponsors, CROs, and tech vendors are expected to follow.
Dustin is optimistic but realistic: “There’s no single owner of this yet. CDISC, HL7, maybe even DiMe could play a role. But right now, we just needed someone to start.”
BYOT may not be perfect, but it’s progress. And in clinical research, where inertia often wins, that’s saying something.