Dec 3 2014
Biotech turns to Veeva Vault to drive efficiency from study start-up to submissions
With an investigational combination biological product in Phase III clinical trials and a recent IPO, Vital Therapies, Inc. is readying its clinical and regulatory operations for global collaboration and greater efficiency with cloud-based Veeva Vault eTMF and Veeva Vault Submissions content management applications from Veeva Systems. Together, the new Vault applications allow Vital Therapies to align document workstreams from study start-up through to submissions. The company is now rolling out Vault as it prepares for its potential first Biologics License Application (BLA) filing.
Veeva Vault – easily and securely accessible in the cloud – enables efficient collaboration between Vital Therapies’ external partners, internal teams across clinical and regulatory, and study sites globally. “We wanted an end-to-end solution that would allow improved efficiency, enable streamlined operations, and provide team members with access to product and study documentation in a structured and secure location. With Veeva Vault, it’s easier to share information,” said Heidi Spanish, director of global regulatory and quality operations for Vital Therapies. “Veeva Vault will also scale to grow with our organization as we drive toward our goal of commercialization.”
Vital Therapies noted the synergy it gains from leveraging a single system for regulated documents. “Veeva Vault connects workstreams between clinical and regulatory, which improves productivity. Users no longer have to pull documents from multiple places,” added Spanish. “And, we no longer need multiple versions of the same document. We now have one version – with content structured largely based on the DIA TMF Reference Model – accessible to teams globally. We used to spend hours comparing different versions, but Veeva Vault saves us time and prevents errors by providing document version control. Vault also reduces time spent searching or chasing down documents when preparing submissions.”
As a growing organization, Vital Therapies wanted to minimize the infrastructure and operational investments that traditional on-premise systems require, and focus its resources on research and development instead. “The cloud is a good way for growing companies to implement advanced business applications like Veeva Vault. System maintenance is provided by Veeva with the option to make changes ourselves or through Veeva’s services. The upgrades to Vault are available regularly, allowing us to enable them as needed for easy access to the latest innovations from Veeva,” added Spanish.
Vault eTMF and Vault Submissions are part of Veeva Vault, a cloud-based suite of integrated content management applications and platform for the life sciences industry. Vault spans clinical, quality, commercial, and medical – every major part of a life sciences company – giving pharmaceutical, biotechnology, and medical device companies the ability to deploy a single content management system globally. Helping companies connect securely in the life sciences cloud, Vault provides complete control from start to finish, as well as the easy accessibility, visibility, and agility needed to speed time to market. All Vault applications offer real-time reporting and dashboards; an intuitive, consumer-web interface; and a true multitenant cloud architecture that continuously delivers rapid innovation.
“The people at Veeva have worked in pharma so they understand our requests and provide good advice. It has been a great experience,” concluded Spanish.