Clinical research sites often struggle with technology adoption, especially with cumbersome, complex and over-priced regulatory management systems necessary to digitize regulatory binders securely and with compliance. TrialSite reported on Veeva Systems’ (Veeva) SiteVault Free initiative as a smart move if the Pleasanton, California-based company could identify compelling business drivers for busy, overstretched sites to find the time to not only deploy the cloud-based technology but also change critical business processes to capitalize on ubiquitous cloud computing opportunities. Apparently, Veeva’s plan is working as the company recently announced over 500 research site organizations in over 30 countries have adopted the SiteVault Free solution. This is a striking number, given the offering was only announced eight months ago. As Veeva positions the cloud-based solution as one that can contribute to not only a streamlined and simplified study management, but also accelerate site activation and study startup through conduct, as well as support sites’ moves to virtual and hybrid studies necessary due to the COVID-19 pandemic, the company’s SiteVault Free may become a ubiquitous standard at research sites worldwide. Given the pharmaceutical sponsors are mostly adopting Veeva for electronic trial master file (eTMF), Veeva opens up a new world of digital connectivity in the traditionally fragmented clinical research environment.
TrialSite recently had Veeva’s Bree Burks, RN, MSN, vice president of site strategy, participate on the TrialSite Podcast; Ms. Burks was a great contributor that the audience appreciated, and it was quite apparent that Veeva’s strategy of hiring talent with deep research domain expertise continues to pay off. As Ms. Burks formerly worked on the site side of the research equation, the company continues to invest in better understanding core site needs for product updates: all in a bid to accelerate adoption. This is exactly what TrialSite suggested was required for success and it appears to be happening.
The Value Proposition
Put simply, a confluence of factors and forces make it more difficult for research sites to manage, seamlessly and expeditiously, study documents that are associated with sponsors, studies and programs from dozens if not hundreds of studies. The content and data management needs can become overwhelming, hence the research site market demands a cloud-based, simple-to-implement-and-use system. Ms. Burks recently commented for a Veeva press release that, “Sites see a tremendous opportunity to reduce the time and effort in managing regulatory binders and improve how they share study information with sponsors.”
Veeva seeks to align its SiteVault Free features, functions and capabilities with research site needs which center on 1) study execution, 2) ongoing digital collaboration to support hybrid and virtual studies, and 3) compliance. Ultimately, a fully utilized and compliant site master file and regulatory binder solution leads to more time and greater focus on caring for patients not to mention the ability to support virtual trials, which makes a site more attractive to sponsors.
Ubiquitous Digitization is Coming to the Site
With over 500 sites now embracing Veeva SiteVault, the momentum now becomes a force as more sites seek a fully compliant system that eliminates manual and paper-based processes with a modern application to manage regulatory and source documentation compliance with 21 CFR Part 11 and HIPAA requirements. Based on a TrialSite review, this product offers all the “must-have” standard features required by the drug development sector, such as electronic signatures, certified copy workflows, and reporting to simplify ongoing compliance.
The demand for remote monitoring only grows post COVID-19 and now that Vault becomes commonplace with not only sponsors but also with sites, Veeva stares at unprecedented opportunity to introduce now possible ubiquitous digitization of workflows and processes between site and sponsor. With ever more hybrid and virtual study demands, authorized remote monitors can access study binders remotely supporting far tighter, more efficient study collaboration across organizations.
A New Standard?
Veeva SiteVault Free has been designed to interoperate with different technology environments and applications. For organizations that invest in SiteVault Enterprise, robust web-based services and common APIs facilitate advanced interoperability. This becomes relevant with so many sites adopting SiteVault Free. Consequently, as organizations make investments in this new infrastructure, Veeva could be on its way to truly helping the research site sector streamline and digitize an area that has for too long been purely manual and paper-based.
Now Veeva can work on building connectors with common research site-side tools, such as site-centric clinical trial management, electronic data capture and source data capture, not to mention regulatory assurance. Moreover, by connecting SiteVault Free to the electronic medical records in larger research sites operations, whether academic medical centers and health systems to what labels “Super Sites”—those private equity-backed site operation consolidators—technological advancement leads to whole new ways to not only streamline clinical trials processes and compliance but also help sites become far more competitive for sponsor business. If the growth continues, sponsors may soon make it a positive requirement that a site has adopted Veeva SiteVault Free.
Recently, Veeva interviewed some of their clients and shared the feedback. Justin Deck, chief clinical officer at Tilda Research, commented, “We are reducing study activation timelines by 40%, spending half the time completing regulatory tasks, and saving tens of thousands of dollars per study with Veeva SiteVault Free” while Hanna Voltattorni, senior project manager at CNS, the largest clinical research provider in Southern California, reported, “COVID-19 halted onsite visits just as we were in the process of locking our study database.” Ms. Voltattorni continued, “Veeva allowed us to continue working with study monitors and keep the trial going. We are now using SiteVault Free across all our studies.”