We have engineered a user-friendly platform that simplifies the distribution of safety documents, including SUSARs and DSURs, with just a single click. This SaaS (Software as a Service) offering not only automates document distribution but also meticulously monitors the entire lifecycle: from delivery to safety, acknowledgments, and sharing with LECs (Local Ethics Committee). It allows to send reminder UNITYdx™ is a multichannel communication hub to ensure prompt, compliant, efficient, and secure communication between Clinical Trial Site, Safety Teams (CRO & sponsor), and Clinical Teams.
Moreover, UNITYdx™ stands out for its convenience and rapid deployment. It is pre-validated system and seamlessly integrates with a wide range of safety databases capable of producing E2B Files, a standard format for reporting adverse events.
UNITYdx™ excels in automating safety document notifications with digital tracking, ensuring that Principal Investigators stay informed promptly. We’ve built UNITYdx™ on a foundation of robust and highly available infrastructure hosted securely on AWS, complete with backup and redundant servers, ensuring uninterrupted service.
Real-time integration of data from disparate sources empowers proactive responses and allows for diligent monitoring of protocol compliance. Beyond SUSARs, UNITYdx™ extends its capabilities to encompass safety document distribution and reconciliation for DSUR’s, and other critical documents within regulated environments, e.g, safety line listing, USRs (Urgent Safety Reports).
In summary, UNITYdx™ is your comprehensive solution for streamlining Safety Document Distribution, improving compliance tracking, and enhancing efficiency across the board. Join us in embracing a new era of safety document management within the regulated realm.