Veeva Pushes Site-Owned eSource as the Final Layer in Clinical Trial Data Capture

Veeva Systems (搜索)搜索该公司 is advancing a site-owned electronic source (eSource) application that its leaders argue represents the final layer in clinical trial data capture, not another digital burden layered onto already overcomplicated site workflows. The product remains in development, with first releases expected by year-end, but the strategic logic behind it carries implications for every sponsor still building site-burden reduction into their protocol assumptions.

At the Veeva R&D and Quality Summit in Copenhagen, Manny Vazquez, Senior Director of Clinical Data Strategy, and Denali Rose, Vice President of Sales and Strategy, Site Solutions, explained why Veeva is approaching eSource differently this time. Their argument is structural: eSource only scales when the site owns it, operates it across its entire portfolio, and the data flows bidirectionally—not just into EDC, but back to the site when queries land.

Why Existing eSource Has Failed to Deliver

For two decades, the clinical research industry has promised that electronic source would liberate site coordinators from duplicate data entry. It has not. Most eSource deployments simply swapped paper transcription for digital transcription: the same burden on a different screen.

"The theory behind eSource has been around for a really long time, but it really just took paper and turned it into something electronic," said Denali Rose. "There was no fundamental change for the site. In fact, it probably added some more work. There might have been some quality controls that helped, but from a site coordinator's perspective, current-day eSource doesn't actually provide much efficiency."

Manny Vazquez framed the problem as a broken workflow that predates any new technology. "The old workflow was broken to begin with. We're not breaking anything, we're fixing issues that already exist," he said. "The ability for a coordinator at a research site to enter a data point once and have it go wherever it needs to go, whether that's EDC, back to their EHR, or straight through to analysis datasets, just entering it once and being done would be a game changer in their current workflows."

Site Ownership as the Structural Differentiator

The central differentiator Veeva is pursuing is twofold. First, the eSource is a site-owned solution: sites own it, operate it, and control it across their entire portfolio, giving them a single way of working across studies and sponsors. Second, the connectivity with EDC extends beyond data flow to include workflow connectivity.

"Sponsors historically have been blind to how sites capture source documentation. That's probably been one of the key cruxes to this challenge for the last ten or fifteen years," Vazquez said. "Sponsors have tried, on a study-by-study basis, to impose electronic source tools on sites with no idea how sites are actually working. Sites have their own processes, their own SOPs. They are the responsible party when it comes to collecting source documentation."

The consequence of sponsor-imposed tools, according to Vazquez, is that they merely replace EDC entry with eSource entry, because the site's workflow does not change and source documentation is still captured on paper. "The way we're going about it is more scalable in the sense that it is not a sponsor decision. Sponsors are the beneficiaries for sites that are choosing to do this for themselves. But it's got to be the site who decides they are going to digitize their own process and build it into their workflow."

Bidirectional Query Workflow and Data Quality

A key feature of the approach is bidirectional connectivity. Sponsors already know what data they want collected in their EDC, and having those CRFs flow to eSource means sites do not have to recreate them from scratch or perform study-specific eCRF builds in their own systems. The data then flows back to EDC, and queries return to the eSource, allowing the site to operate in one system for both workflows and data.

Vazquez described how this handles data entry errors that make it through to EDC. "Source data is not necessarily clean data. There's still a need to review and have those types of checks built in. But that's the beauty of the bidirectional capability: when data does push through to EDC, EDC is still going to do the checks and the validation. If it finds anything that requires a query, it will trigger it back, and the site will get that feedback in their eSource window."

Because anything that comes through to EDC is by default source, there is no need to source-verify it. "As far as the sponsor is concerned, it's all direct data capture. Anything that comes through on the other side in EDC, they know it's source," Vazquez said. "We haven't quantified it yet, but I think we can reasonably assume there will be significant cost savings in source data verification, because you wouldn't have to do that for data that comes through this way."

Rose added that electronic source reduces re-keying from the EHR, cutting the opportunity for transcription error by design. "It's one entry versus two. And there are checks you can build in: if something is ridiculously out of range, say you put in blood pressure 380 instead of 180, the system will flag it."

Returning Time to Patient Care

Rose framed the value of eSource in terms of what site coordinators can do with recovered time. "The expectation is that when they go live on eSource, they get some of those efficiencies back. I think the reason a lot of sites are in this business is to take care of patients. That's the boots-on-the-ground work. Any time you can give that time back to site staff, they can put it back into what matters most, which is doing the actual science and taking care of the patients."

She drew a parallel to the EHR space, where providers initially found digital tools difficult but, as tools improved, could pay more attention to patients. "I would expect something similar in clinical trials, especially where patient retention is such a challenge. The more human we can be about it, the better retention rates can be. We need to get the technology out of the way of that and give them time back."

Removing Barriers to Adoption

On the cost of waiting, Rose noted that for any site running under twenty-one trials, eSource follows the same model as SiteVault and CTMS: there is no cost. "So for those sites, there's no barrier. They could do it now."

Vazquez added that from a sponsor perspective, the change is site-driven and the value lands with sponsors as beneficiaries: reduced source data verification, sites delivering data digitally, and the potential to build automation and AI on top of fully digitized source data. "We'd all love to see paper removed, transcription removed, and a fully end-to-end digital workflow so we can build the AI on top of it that we all know is coming."

The Role of FHIR in Scaling eSource

The broader industry context, as articulated by Veeva's Nick Frenzer, general manager of Veeva site solutions, points to Fast Healthcare Interoperability Resources (FHIR) as the technical foundation for scalable eSource. FHIR, a standard by HL7 International, enables the secure exchange of health data and is now largely seen as the industry standard.

"Before FHIR, data integrations were often complex, custom built, and a security risk," Frenzer wrote. "By using FHIR and applying it to clinical research integrations, organisations gain the ability to share patient-level data queries in a secure, regulated environment."

FHIR-based API standards allow for the precise, automated transfer of audit-ready data elements, providing the foundation to integrate with EHR systems and realize data flow from EHR to EDC. This interoperability is what makes eSource scalable beyond a single study, rather than relying on bespoke, expensive single-use EHR-to-EDC integrations.

Frenzer emphasized that making a site-owned eSource successful will require industry buy-in and alignment across sites, sponsors, hospitals, regulators, and technology providers. "Rethinking what eSource is, its role in clinical trials, and how it can be scaled across studies is an important first step. Together, sites and sponsors can continue to work towards clinical trials that are standardised, simpler, and more connected to help improve patient health."