Innovative Companies Share their RIM Strategies at Veeva R&D and Quality Summit

At this year’s 2020 Veeva R&D and Quality Summit Online, we heard how emerging biopharma companies are centralizing regulatory information, streamlining processes, and establishing a solid foundation for growth.

Rusty Ang of SeaGen described how the fast-growing company replaced email, spreadsheets, and file shares with a single system for managing submissions, health authority interactions, registration tracking, and published dossier archiving and viewing. He was joined by colleagues H Bondar and Verchel Wunpheng, who each shared lessons learned from their Vault RIM implementation, including strategies to improve user adoption and manage the migration of existing documents and data. Lastly, the SeaGen team provided a look ahead into their plans to implement cross-Vault connections for regulatory, clinical, and quality.

In a follow-up to last year’s Vault Submissions Publishing panel, Veeva welcomed back Anthony Ochoa from Myovant along with Lisa Pitt and Ayesha Ullah from Viela Bio and Jason Maze from Dermavant. They discussed how a continuous publishing approach creates process efficiencies and provides real benefits for smaller teams looking to advance regulatory operations.

Attendees also heard from Craig Gassman of Vericel who shared five simple configuration updates for Vault Submissions that put more information at users’ fingertips. The updates—all driven by user feedback—include a dashboard that provides one-click access to commonly retrieved documents like correspondence and approved labels.

Matt Neal from Atara Biotherapeutics explained how Vault RIM has evolved into a platform for growth and competitive advantage, simplifying the day-to-day work for integrated regulatory teams. Neal also advocated for risk-based validation to promote agility and accelerate the delivery of business value to end users. In the same session, Scott Cleve laid out bluebird bio’s plans to leverage more of Vault RIM’s capabilities that go beyond document management. The initiative will transform Vault RIM from a “place to upload documents” to a strategic asset that supports regulatory processes and decision making.

Arcus Biosciences closed out the regulatory track by detailing their journey from a disjointed environment of email and SharePoint sites to the company’s first-ever validated RIM system. Patty Carlos, Lisa Owens, and Mike Tarsa reviewed their considerations for IT infrastructure, business processes, system configuration, validation, data migration, and training.

Thanks to our presenters for sharing their experiences and insights. To view these and other Summit sessions on demand, please click here.