inVentiv Health Clinical, a Princeton, N.J.-based global supplier of drug development services, will replace its electronic trial master file (eTMF) content management system with California-based Veeva Systems’s Veeva Vault eTMF.
Cloud-based, multitenant Vault eTMF delivers secure, instant access to inspection-ready documentation and enables collaboration between CRO, sponsors and sites worldwide—ultimately helping to speed time to submission and product approval.
“With Vault eTMF, we believe we can provide sponsors with transparency of trial data and enable a richer, more collaborative partnership for improved trial results, including faster time to market,” said Gregg Dearhammer, chief operating officer at inVentiv Health Clinical.
Vault eTMF is preconfigured with the Drug Information Association (DIA) TMF Reference Model for a repeatable framework across the enterprise. It supports inspection-readiness with workflow, reports and dashboards, plus features robust audit trails and an auditor role that supports remote inspection capabilities for sponsors and health authorities.
“Vault eTMF should simplify the entire drug development process, minimizing duplication and improving collaboration, not only across our own teams but with our clients,” said Rachel Stahler, chief information officer at inVentiv Health Clinical. “And the cloud-based solution should allow us to provide more efficient contract services to our customers in a rapidly changing landscape.”
Vault eTMF also enables shared visibility for participants so that the most current status of trial-related documentation is available at any time. Additionally, Vault Investigator Portal makes collaboration with site personnel easy for faster study start-up and more efficient operations overall.