Veeva Systems and Kinapse Ltd., a provider of life sciences advisory and operational services, announced that Kinapse has selected Veeva Vault Submissions to power its new regulatory operational services. Veeva Vault Submissions provides Kinapse a modern cloud application for authoring and managing regulatory submissions content. Kinapse will now offer sponsors the option to produce regulatory deliverables on Vault Submissions and leverage Kinapse’s new efficient processes that have been optimized on Veeva’s cloud platform.
“Service providers play an increasing role in regulatory operations today,” said Katrin Spaepen, director of Vault RIM Strategy at Veeva Systems. “Veeva Vault Submissions will provide Kinapse customers a shared authoritative source for submissions content. Combined with Kinapse’s services, sponsors can achieve global accessibility and real-time visibility into their regulatory submissions processes.”
Today there are two ways sponsors work with regulatory submissions service providers. Sponsors have service providers access their on-premise systems remotely, slowing performance and limiting innovation by constraining the service provider to follow the sponsor’s model of operation. Alternatively, sponsors author, review, and approve submission documents within their own systems then manually transmit documents to submission partners. This makes document changes difficult to track, creating inefficiencies and increasing risk.
“Veeva Vault Submissions changes how sponsors and their partners collaborate by providing fast, direct access to manage content and data,” said Marc Gabriel, client partner at Kinapse. “Veeva Vault ensures submissions are managed with greater quality, efficiency, and control by allowing the sponsor and service provider to access their documents and data through the cloud and view status in real-time.”
Kinapse is coupling Vault Submissions with a new set of streamlined regulatory processes that take advantage of Veeva’s advanced capabilities for regulated document management. Kinapse rigorously tested the platform’s key functions, including the segmentation of client data. The Kinapse regulatory team is trained and ready to deliver submissions on the Vault platform.
“There is significant interest around Veeva’s unique cloud applications for regulatory information management (RIM),” said Aileen Fisher, vice president of Regulatory Affairs and Pharmacovigilance Services for Kinapse. “With Veeva Vault Submissions, we expect our customers to benefit from greater access, visibility, and control over their submissions information and, ultimately, speed their time to submission.”