By Benjamin Ross

October 3, 2019 | Veeva will soon be offering a free, widely available version of their eRegulatory solution SiteVault Enterprise—called SiteVault Free—to clinical research sites that would otherwise be unable to invest in a clinical research technology that would assist them in managing regulatory documents and trial information.

Planned for release in December 2019, the free edition of Veeva SiteVault Enterprise supports an unlimited number of users and comes with full customer support from Veeva.

SiteVault Free's capabilities are similar to SiteVault Enterprise, Jason Methia, VP of Site Strategy at Veeva, tells Clinical Research News, though the delivery model varies. SiteVault Enterprise is implemented by Veeva at the site level, allowing the site to configure the application to their specific needs, while SiteVault Free is available to any site to signup and use as their electronic Investigator Site File on all trials that they run.

Methia says Veeva has been thinking more broadly about how they could assist the clinical research industry as a whole, from the sponsors and CROs to the clinical research sites themselves. During SiteVault's launch last year, Methia says Veeva paid attention to the clinical research site market as a whole.

"It's a big market in terms of the number of sites that are out there, but many of those sites are very small organizations with limited resources," says Methia. "About 80% of the clinical research sites are running less than ten trials a year."

Veeva wanted to find a way to plug into the wealth of untapped potential in that 80%.

"We wanted to bring a different approach to the clinical research site technology market as a whole," Methia says. "Traditionally you have top-down deployment models of technology, the top being sponsors and CROs and the bottom being the sites. 99% of the time you have the sponsors and CROs offering technology to the clinical research sites. While well intentioned, the challenge with that at the site-level is that sites are inundated with all this technology, and the majority of the time sites say the technology does very little to support their business process."

This overflow of technology often requires exclusivity from the site, where an application provided by a sponsor for a specific trial can't be used for a trial from another sponsor.

Veeva didn't want to simply propagate this issue, Methia says. Supporting the site's workflow, while also allowing the site to use the application on any trial they want after they've signed up for the service, was a key capability for the free solution.

"If we give sites more access to [services like SiteVault Free], then maybe the use of that technology can result in better success at the site level. So not only are they more efficient and more compliant, but you get less administrative burden because we're providing a level of infrastructure that those sites wouldn't otherwise have access to."

No Site Left Behind

That infrastructure is in great demand from a site perspective, where these burdens are often seen as merely examples of working in the complex world of clinical research.

Rachel Sheppard, Clinical Regulatory Director for the Clinical Trials Unit at the University of Louisville (an early adopter of the SiteVault Enterprise), says the research site is often brought in at the tail-end of the discussion of how to improve research at the site level, leaving the site feeling as though they work for a system rather than having a system support their work.

"The problem with having a sponsor select a product rather than selecting our own product is that every study is going to have a different platform or portal that we need to use," Sheppard tells Clinical Research News, "and we need to remember which one goes with which project, which is a bit of a logistical issue for us."

Sheppard says the number of platforms her team was handling became so logistically taxing that they had to build tools within their clinical trial management system (CTMS) that would track which platform went with which study.

"If I'm working on study A today, I'll be in this portal, and then tomorrow I could be working on another study and I'm using a completely different portal," she says. "This is true from a regulatory side, but my clinical team also has to think about not only where some of the essential documentations need to go, but they also need to deal with a system to randomize their subjects, another system for electronic data capture, and maybe even another system to enter their adverse events."

Sheppard believes sites are now moving toward having a seat at the table.

"It's an ongoing task to keep your finger on the pulse of what's going on," she says.