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.
Disclaimer:
Copyright 2023 by Soterius, Inc. All rights reserved. Soterius logo are trademarks or registered trademarks of Soterius in all jurisdictions. Other marks may be trademarks or registered trademarks of their respective owners. The information you see, hear or read on the pages within this presentation, as well as the presentation’s form and substance, are subject to copyright protection. In no event, may you use, distribute, copy, reproduce, modify, distort, or transmit the information or any of its elements, such as text, images or concepts, without the prior written permission of Soterius. No license or right pertaining to any of these trademarks shall be granted without the written permission of Soterius (and any of its global offices and/or affiliates). Soterius reserves the right to legally enforce any infringement of its intellectual property, copyright and trademark rights.
Any content presented herewith should only be considered for general informational purposes and should not be considered as specific to the requirements of any particular organisation or for any specific purpose. Soterius does not make any representations or warranties about the completeness, reliability, appropriateness, relevance, or accuracy of the content presented here.
