Xogene, a leader in clinical trial transparency solutions, announced the launch of Prime 4.0, the latest release of its end-to-end disclosure management platform. The release introduces significant changes to form architecture, data syncing, and overall system usability — designed to reduce manual effort and improve accuracy across multi-registry disclosure workflows.
Prime 4.0 solves a defining challenge for transparency teams: keeping disclosure consistent across a growing and complex registry landscape. The new configurable form architecture lets clients define a primary form around their common data elements, capture registry-specific variations, and route everything through a structured review and approval process — ensuring consistent, accurate disclosure every time.
What's New in Prime 4.0
- Configurable Form Structure: A configurable primary form replaces the legacy global form, with registry views that can be enabled or disabled — giving transparency teams the flexibility to work in alignment with their disclosure strategy.
- Intelligent Form Syncing: Data and comments sync seamlessly across the primary form and registry views, eliminating duplication and ensuring records remain consistent across every registry.
- Improved EU CTIS Results Support: Enhanced assessment logic supports recurring assessments to meet CTIS interim analysis date requirements, alongside a dedicated EU CTIS Results form aligned with Annex IV field names and formats for accurate, structured results disclosure.
- Enhanced Collaboration: Upgraded commenting with @mentions, threaded replies, and visual enhancements for seamless collaboration across transparency and study teams.
- Usability Improvements: A suite of dashboard and navigation enhancements — including recently viewed studies, pinned reports, enhanced version compare, and frequently cc'd email functionality — designed to reduce friction and keep teams moving efficiently.
- Form Microservice: Registry form updates can now be delivered outside of standard release cycles, giving clients faster access to the latest registry requirements and reducing the gap between regulatory change and system readiness.
"Transparency teams have been working around rigid systems for too long," said Renita Cuccia, VP of Product. "Prime 4.0 changes that. Sponsors can now configure Prime around their own disclosure strategy — so whether they're managing global or local registries, or both, they have a clear plan, a primary form built around the registries they choose to track, and greater control over what gets disclosed. That's a fundamentally different experience.”
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Founded in 2010, Xogene specializes in clinical trial transparency solutions, serving more than 45 leading pharmaceutical and life sciences companies. Xogene’s Transparency Cloud platform streamlines regulatory compliance processes across the disclosure lifecycle. Xogene’s disclosure services provide end-to-end support for protocol registration, results posting, and plain language summaries. Serving clinical trial transparency, regulatory affairs, and medical writing teams, Xogene combines domain expertise with innovation to address evolving disclosure requirements.
