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The TransCelerate consortium is an early adopter
For several years, Veeva Systems, which started as a supplier of cloud-based salesforce automation tools, has been building out a cloud-based offering for clinical research in life sciences. Now, that Vault Clinical Suite is expanding to include Vault SiteExchange, enabling clinical teams and site investigators to consolidate study document requests, workflows, notifications and alerts in one place, and streamlining interactions with study sponsors, clinical research organizations (CROs) and others involved in a study. Significantly, the clinical team has full visibility into interactions across multiple clinical trials; no need to sign out of one trial portal and onto another (as long as all these trials are themselves available on SiteExchange).
Vault, as its name indicates, is an online storehouse of information, organized in alignment with the data-integrity, identify-protection and verification requirements of FDA-regulated research and healthcare content. Jennifer Goldsmith, SVP at Veeva, adds that SiteExchange provides a standardized user interface for site teams; the combination cuts the time spent by investigators in logging onto and interacting with data repositories, which can be an impediment to successful trial administration. SiteExchange readily communicates to other Veeva Clinical Suite applications (Vault EDC, Vault eSource, Vault CTMS, Vault eTMF, and Vault Study Startup); some application program interfacing is carried out to link to others’ systems.
Simultaneously with the product announcement, Veeva says that the TransCelerate Biopharma Inc. consortium of biopharma companies (all of which would be site sponsors) has agreed to incorporate SiteExchange into its Shared Investigator Platform, an initiative to provide the industry with a centralized platform that will be interoperable with various clinical solutions, streamline communications between investigators and sponsors, and reduce redundant requests during a trial. A preferential subscription rate has been negotiated between Veeva and TransCelerate, whereby TransCelerate members (currently 18 major pharma companies globally) can choose to use the service. (Non-members can negotiate directly with Veeva for the product.)
“Veeva is a proven technology innovator and cloud leader with an excellent track record in driving greater efficiency in clinical operations,” said Janice Chang, SVP of global operations at TransCelerate, in a statement. “The integration of Veeva Vault SiteExchange with the Shared Investigator Platform further simplifies site administrative efforts, which is core to one of our strategic priorities to improve site experience.”
TransCelerate was founded in 2012 to address a variety of industry-wide issues in R&D, specifically where a standardized or shared approach would simplify R&D processes across the board; it has successfully tackled processes for sourcing comparator drugs; shared toxicology data; templates for trial reports and other concerns. Veeva itself recently initiated another industry consortium, Align Biopharma, to address sign-on and identify-management processes for clinical research communications. In a neat bit of circularity, both Veeva and TransCelerate recommend a sign-on system offered by Exostar (although other sign-on systems can be specified).