When The System Breaks, Who Pays? SCRS On Site Tech Gaps
By John Oncea, Chief Editor, Clinical Tech Leader
Jimmy Bechtel describes himself as an executive leader driving clinical research sites and healthcare professionals toward sustainability. Eight years at the Society for Clinical Research Sites (SCRS) – starting as a Senior Project Manager before ascending roughly a year ago to Chief Site Success Officer – have given him an unusually clear-eyed view of the industry’s pressure points.
He came up through both sides of the business: data specialist, patient recruiter, and operations manager on the site side, then innovation project lead on the sponsor side at a major pharmaceutical company. That dual vantage point informs everything he does at SCRS, where he shapes strategic direction across membership growth, education, and industry partnerships, including the Site Advocacy Group program and Global Impact Partner collaborations.
An Architecture Problem, Not A Training Problem
The SCRS Site Technology Challenges and Solutions framework is direct about what’s breaking down at the site level. Stand-alone systems that don’t talk to each other, duplicate data entry, password sprawl across disconnected platforms – these aren’t edge cases. They’re the daily operating reality for sites trying to run multiple trials on technology they didn’t select and can’t control.
I asked Bechtel how receptive sponsors and tech vendors have been to SCRS’s recommended fixes – Single Sign-On, deep linking, eSource-to-EDC, and eDiary/ePRO-to-EDC integration.
“Receptivity varies widely, and movement is slow,” he said. “The recommendations in our Digital Innovation Initiative came directly from site-level frustration, not from sponsors or vendors proactively raising their hands. That tells you something about where the pressure is originating.”
He noted that some forward-thinking vendors have engaged constructively, particularly through SCRS’s IncluDE program, which champions this kind of interoperability work. But broad adoption requires sponsors to prioritize integration as a selection criterion when contracting with vendors, and that shift, Bechtel said, is still inconsistent.
The data he cited puts a finer point on it: Eighty-six percent of sites that reported losing revenue from digital solutions identified difficulty coordinating technology as the top cause. “That’s not a training problem,” Bechtel said. “That’s an architecture problem.”
That framing matters. The instinct in the industry has often been to solve technology friction through more education, onboarding sessions, user guides, and training hours. Bechtel’s point is that no amount of training compensates for systems that were never designed to work together in the first place.
What Sites Can Do Now
I asked what the most practical near-term move is for sites that can’t wait for the industry to catch up.
Bechtel’s answer was pragmatic: identify which data flows are the highest volume and highest risk, then advocate specifically for intermediate integrations on those pathways, even if full interoperability isn’t on the table yet. He also pointed to a specific role that has made a measurable difference for SCRS members: a dedicated technology coordinator at the site level, someone who owns cross-system workflows and manages technological needs by leading implementation.
He also was quick to note that not all sites are waiting for sponsors to act. “We’re seeing 22.5% of sites already using AI and technology tools to find internal efficiencies,” he said. “Those sites aren’t waiting for sponsors to solve this.” For sites that haven’t started, his advice was direct: find your redundancies, document the time cost, and bring that data to your next budget negotiation. “If you can’t bring real data to the table, the sponsors aren’t going to respond.”
On the question of sponsor and CRO data ownership restrictions – which SCRS identifies as a specific barrier to high-level integration – Bechtel acknowledged that the conversation is happening but isn’t fully bilateral yet. “Forty-nine percent of sites cite sponsor-driven causes as their top delay factor for study disruptions,” he said. “Ownership and integration restrictions are part of that pattern. What I’d like to see – and what we’re pushing toward – is sponsors treating data flow as a shared responsibility, not a unilateral design decision.”
The Gray Area Nobody Has Fixed Yet
The regulatory portion of the SCRS framework touches something the industry tends to handle informally: what happens when remote technology fails, and who’s responsible?
The ambiguity is real and specific. When a sponsor-mandated tool goes down mid-trial, questions around delegation, liability, and oversight don’t have clean answers. Insurance policies written before decentralized trial conduct was commonplace don’t map neatly onto the scenarios sites are actually encountering.
“Most sites are navigating this informally right now, relying on PI judgment, trying to document everything, and hoping their existing insurance covers situations that frankly weren’t written with decentralized trial conduct in mind,” Bechtel said. “That’s not a sustainable posture.”
SCRS has formally positioned indemnification of sites for technology they don’t own or manage as an advocacy goal. Standardized contract language is the objective, but Bechtel was candid about where things actually stand: “It doesn’t fully exist today.” In the interim, he said, SCRS is working to equip sites with the right questions to ask, the language to push for, and the ability to flag gaps before they sign with supporting guidance through the IncluDE program.
The global dimension adds complexity. Bechtel described the ambiguity as genuinely universal, with SCRS survey data spanning North America, South America, Australia, New Zealand, Europe, and Africa. But certain regions carry a compounded burden, such as Latin America and Africa, where regulatory infrastructure around digital health is less mature, and the technology being deployed was designed for entirely different frameworks. In Europe, the evolving Clinical Trials Regulation creates additional layers for sites operating across multiple member states.
On the question of whether indemnification is a realistic near-term ask, Bechtel didn’t oversell it. “It’s aspirational today,” he said, “but it’s becoming more legitimate with every trial that relies on sponsor-mandated technology.” The data is building a case: 22% of sites have already lost revenue or profitability from digital solutions, and the top causes are system-level failures, not site errors. “That shifts the conversation from ‘sites should be more careful’ to ‘sponsors should share the risk.’”
The industry isn’t there yet. But Bechtel believes the evidence base is being built through advocacy, and through the continued accumulation of data showing exactly what sites lose when tools they didn’t choose fail.
Jimmy Bechtel is Chief Site Success Officer at the Society for Clinical Research Sites (SCRS). This is the first of two articles drawn from a recent conversation. The second (live on April 30!) examines SCRS’s Bring-Your-Own-Tech challenge and what it reveals about where sites – and the industry – are headed.