Veeva, recently a topic here at TrialSite News, now pushes the envelope in an industry it has already disrupted. By offering SiteVault Free at no charge to clinical investigational sites, the California-based, life science cloud-software company can transform sponsor to site digital engagement even more.
Clinical research sites range from major academic medical centers, therapeutic area collaborative networks and patient-based non-profit therapy-based associations to health systems and small physician-owned practices. Of course, we have reported on the growing number of private equity infusions into site role up models and extending site networks.
Many sponsor-side technology vendors don’t understand clinical investigational site business processes and challenges. A growing body of evidence suggests sites are under tremendous pressure from industry sponsors with hundreds of different applications they must access and interact with on a daily basis. There have been attempts to alleviate the site-side pain—for example, the Transcelerate initiative launched an shared investigator platform years ago, but it never evolved into a widely used system. Sites need their own repositories with document management and compliance features. not to mention the ability to organize investigator site master files (also electronic investigator site files or eISF) while also having a more compelling and seamless way to interface with multiple sponsors.
But most sites still store their regulatory binders, for example, on paper. Many of the larger research centers utilize generic document collaboration and extranet tools such as Microsoft SharePoint, Box, and DropBox, but these are not designed for compliance nor for purpose-built site-centric workflows, document management, and site master files (let alone digital regulatory binders). Vendors such as Forte have supplied large academic medical centers with a site-side clinical trial management and data capture system, but only the bigger centers typically adopt such systems. Moreover, upstarts such as Florence have developed site-side trial master files for “digital regulatory binders” but they have struggled to achieve necessary growth and now seek to position to sponsors because they have learned that selling into sites is a tough business.
Vendors have developed one-off sponsor-side portals that offer site-focused, purpose-built document exchange but they cannot, by regulation—support models where the sponsor exploits such systems to management and control the site-side site master file. Moreover, these are sponsor-centric portals and hence, don’t solve the fundamental site-level problem of too many sponsors systems for sites to access. Again, Transcelerate sought to offer a common site interface on behalf of a group of large pharma companies but this was still a sponsor-side solution, not designed for sites and their specific challenges—it was too “Big Pharma” focused.
Veeva has swept through the industry with their eTMF system now commanding the largest market share among big industry sponsors. Veeva has been attempting to bridge the gap between sponsor eTMF and site eISF for some time now but never really understood what kind of bridge needed to be built. They did mobilize a team to sell Vault to sites directly and found that sites really didn’t have a lot of disposable cash laying around.
But in that process of marketing the Vault into the site world they concluded that no site should be left behind. Why not offer a version of Vault—called SiteVault for free?
Veeva announced two versions of SiteVault including 1) SiteVault Free and 2) SiteVault Enterprise. Veeva commits offer compliance support for both versions.
We include a basic comparison of the two packages:
|Standard Features||SiteVault Free||SiteVault Enterprise|
|Full eReg System||Yes||Yes|
|Auto-Filing & Naming||Yes||Yes|
|Secure Cloud Platform||Yes||Yes|
|Configurable Workflow & User Groups||No||Yes|
|Self Service Dashboards & Reports||No||Yes|
|Real Time Collaborative Authoring||No||Yes|
|Enterprise Single-Sign On||No||Yes|
|Unlimited Document Retention Period||No||Yes|
Veeva SiteVault Free is a smart idea. They have already secured a significant portion of market share on the sponsor eTMF side of the market. Now, by offering sites a free Vault that can be validated, they are accepting a reality in the site market—that there isn’t lots of disposable cash laying around. Even in the larger university settings with significant research grants and endowments, they are known to watch the spend and use technologies such as SharePoint that their IT departments access as part of enterprise license agreements.
eTMF to eISF
By offering sites SiteVault Free they can potentially accelerate the adoption of Veeva Vault at the site level. If the user experience goes well, the word will spread and more sites may sign on for the free, validated version. As more and more sites use Vault and become acclimated to the technology, the navigation, and the interface, the more comfortable sites will become, and they will start to consider extending and enhancing their Vaults and hence will upgrade to the SiteVault Enterprise version (assuming it is priced fairly) as they can then configure workflows, reporting as well as integrate with clinical trial management and site-side EDC systems, for example. Sites may even start using SiteVault for the electronic site file (eISF) as well as electronic regulatory binder—replacing the big paper binders that still exist today.
If that were to occur this will map nicely to the sponsor eTMF which for most pharma companies is now Veeva Vault. A few years from now if most of the sponsors utilize the Veeva Vault eTMF and a great number of sites are using SiteVault Free or Enterprise then Veeva will have a lock on the clinical trial document exchange and collaboration market heretofore not possible.
Because in parallel, Veeva can start bridging the two with interoperability standards via their Align Biopharm single sign-on standard or other approaches, such as the emerging Webauthn, effectively accomplishing what big pharma tried to do with Transcelerate but without imposing one collective sponsor platform. Rather, their cloud-based document and data management solution could become so pervasively adopted it becomes the de facto standard for clinical trials document collaboration between sponsor and site
Sites should be careful to do their due diligence with any technology. Not only do they want to understand their own document management, site master file, and digital binder requirements, but they also want to assess what other systems needs to be purchased or upgraded to support continuous improvement in quality, safety and productivity. Sites need to understand how the different clinical trials applications need to not only be upgraded but how they will fit together. Sites must do this to be competitive. Service level agreements should be scrutinized—everything from vendor support response and resolution times (and associated service credits) to disaster recover models and data ownership. Sites must ensure they own their own data. The Veeva offering sounds very good, but details must be understood.
Clinical research site markets are undergoing a transformation. Industry sponsors are moving from blockbuster to precision studies making clinical research more complex and competitive. Sites must market themselves as organizations that continuously improve quality, patient safety and productivity to be competitive. A document management system that supports electronic investigator site files represents a key enabling infrastructure and Veeva has made a bold move with their SiteVault Free.