Why Clinical Trial Sites Are Drowning In Tech Chaos

By John Oncea, Chief Editor, Clinical Tech Leader

Technology has been woven into clinical research for decades – ePRO, mobile health, wearables, AI-driven decentralized trials, real-time patient monitoring. It isn’t going away, and most people working in this space don’t want it to. The problem isn’t the presence of technology. It’s the accumulation of it, layer by layer, without the integration needed to make it work.

Attendees of the Clinical Tech Leader Live event, Managing The Tech Stack In Today’s Trials, made this plain when nearly half – 45.5% – identified too many systems and a lack of integration as the primary drag on their operations. That number aligns with broader data: the National Center for Biotechnology Information reports that 59% of trials are hindered by multiple disconnected systems, and two-thirds of sites say technology setup, training, and implementation are more burdensome today than they were five years ago.

Technology has ranked among the top three site complaints for years. Within that category, the single biggest sub-issue right now is data entry across systems that don’t communicate – sites copying, pasting, transcribing, and building manual bridges between platforms that were never designed to connect.

This article is the first of a three-part series. Click here for part two, and click here for part three.

The Six-Week Problem Nobody Talks About

Research from the Tufts Center for the Study of Drug Development adds an even more concrete dimension to the burden. It takes six weeks on average for sites to receive the final core documents they need just to begin protocol-guided source preparation. Eighty-six percent of sites flag the final protocol as a rate-limiter to study activation. Eighty percent flag the final informed consent form. Seventy percent flag the final case report form. Sites are stuck before they’ve even started.

Beth Harper, Senior Research Consultant at the Tufts Center for the Study of Drug Development, is direct about where the misunderstanding lies. The industry has spent a disproportionate amount of energy trying to integrate with site EMR systems as though that were the universal answer to site burden. It isn’t. What sites actually need is more fundamental: the right information, delivered consistently, so they can create source documents without working around contradictions in the materials they’ve been given.

“The information is often disparate, inconsistent,” Harper said. “It’s not just about eSource, it’s much broader than that.” Sites, she noted, would often rather see sponsors spend effort integrating their own systems – EDC to IRT to ECOA – than trying to retrofit themselves into site workflows that sponsors don’t fully understand.

Sites Are Already Investing, Sponsors Aren’t Asking

A persistent myth holds that sites are resistant to technology or lack the sophistication to adopt it. The data doesn’t support that. Harper cited Tufts’ research showing that 40% of sites have been investing in their own technology since at least 2000, building their own systems to make their research operations more efficient, independent of what any individual sponsor requires.

COVID accelerated that trend. What didn’t accelerate was the corresponding conversation on the sponsor side. Sponsors, according to Harper, often don’t ask sites what they already have. They assume they know, or they assume the site is too busy to respond. Both assumptions are wrong.

Rosie Filling of Keenova Therapeutics put the structural issue plainly: every site is different. Not just in terms of size or geography, but in terms of priorities, resources, staffing, and the specific pressures they’re navigating at any given time. A site running studies for 20 or 30 different sponsors simultaneously cannot be expected to reshape its operations for each one. The idea that any single technology configuration could work uniformly across that landscape is, as she put it, simply not feasible.

“Design with them and not just for them,” Filling said, a formulation that captures the shift the industry has been slow to make.

The Hidden Layer Of Manual Work

Joe Dustin of Dauntless eClinical Strategies described a layer of site work that most people outside the site never see. Sites aren’t just moving data from one system to another. They’re frequently building intermediate worksheets, manual workarounds that allow them to get data into the correct order and satisfy protocol requirements before it ever reaches the EDC.

The example he offered is instructive: if a protocol requires two blood pressure readings but the database only needs one, there’s no built-in place to document the second. Sites solve this by creating paper worksheets in the middle of the workflow, extra work that consumes time and staff resources, and that technology was supposed to eliminate.

“I’m hiring people and paying them to do work that should be automated,” Dustin said. Site surveys from Tufts and SCRS consistently place technology among the top three complaints, alongside delayed payments and insufficient recruitment support. Within the technology category, data entry – specifically the manual, multi-system kind – sits at the top of the list.

Language Gets In The Way Too

Harper raised a subtler obstacle: the vocabulary sponsors use when asking about site technology is often too vague to generate useful answers. Asking whether a site is “tech-enabled” or “tech-savvy” tells a sponsor almost nothing. A site can have an EMR and not use it for research. A site can be deeply sophisticated in one area and entirely paper-based in another.

The better questions are specific: Does the site have its own eConsent system? An ePayment platform? An ECOA tool? eLab portals? eSource capabilities? Those answers reveal what already exists and what might realistically connect without adding burden.

Filling added that when sponsors don’t ask, sites should advocate for themselves, during feasibility surveys, at pre-study visits, wherever the communication channel exists. Joint communication has to flow in both directions. Sponsors won’t know what sites have unless sites tell them, and sponsors won’t ask unless they accept that they don’t already have all the answers.

The Real Question Facing The Industry

The narrative that sites are the problem – that they’re resistant, under-resourced, or behind the curve – doesn’t hold up to scrutiny. What the data shows instead is that sites have been building, investing, and adapting for decades. What’s lagged is the sponsor-side willingness to meet them where they are, ask the right questions, and design systems that work with existing site infrastructure rather than against it.

That has practical consequences. If sites are already building workarounds to survive the sponsor’s tech stack, then the stack itself is what needs to change. The real question is not whether sites can keep up; it’s whether sponsors are willing to stop creating unnecessary work for them.

That question leads directly to a more contested issue: when both sides have technology in place, who actually gets to decide which stack wins? That integration dilemma, and the economics behind it, is explored in the second article of this series, The Integration Dilemma: Who Decides Which Tech Stack Wins?