Florence eBinders

Streamline regulatory operations across your organization to improve compliance and advance research. Veeva SiteVault reduces the complexity of conducting clinical trials by connecting your regulatory operations to improve efficiency and compliance. Manage regulatory and source documents in a single system that supports 21 CFR Part 11 and HIPAA requirements. With a real-time visibility across trials, SiteVault Enterprise improves operational efficiency, speeds study activation, and enables faster, higher-quality trial execution. Replace manual processes and design your own workflows to support quality and speed study activation. Eliminate the need to grant EMR access or redact documents by providing monitors with secure, direct access to your regulatory and source documents. Create your own workflows, reports, and dashboards for greater visibility into start-up timelines and regulatory processes.

oomnia is a real-time SaaS platform that unifies all essential clinical trial tools-EDC, RTSM, CTMS, eTMF, eCOA, ePRO, and eConsent-into one cohesive system. With single sign-on, users save up to 75% of time spent navigating between systems. Its multi-tenant design allows stakeholders to manage multiple trials on a single instance and gain oversight of entire portfolios. No coding is required due to intuitive drag-and-drop features. oomnia is fully interoperable, eliminating integration issues, and offers role-based access with a user-friendly interface customizable by language and notifications. Real-time reporting, seamless randomization, and complete audit logs enhance efficiency and data accuracy. The platform complies with 21 CFR Part 11, EU Annex 11, and CDISC standards. ISO 27001 and ISO 9001 certified and FDA/Swissmedic inspected, oomnia enables up to 50% time and cost savings through streamlined, intelligent trial management.