PHARMACOVIGILANCE & SAFETY TECHNOLOGY SOLUTIONS
Our Technology Solutions use state-of-the-art technologies to solve complex safety operations problems, be it case processing, intake, site reporting for clinical trials, or literature search and management. We have one of the most accurate solutions for case intake and case processing using artificial intelligence.
Our complete literature abstract and full-text article processing software platform allows automatic intake, categorization, annotation, and pre-processing of an ICSR so that it can be processed and transferred as a near-ready case in E2B format into a safety database. The platform allows for reporting for signal detection, aggregate reports, and in-depth data mining. The system is fully validated and new clients addition on our multi-tenant SaaS-based platform takes a matter of days to configure and roll out.
Soterius offers its in-house tool, UNITYdx, which automates the sending and tracking of SUSAR notifications to the Principal Investigators (PI) during a clinical trial. System integration and standardization allow UNITYdx platform to work with any of the database systems. Continuous tracking provides audit reports and tracking for inspections. Multi-channel communication hub ensures prompt, compliant, efficient, and secure communication between Clinical Trial sites, Safety Teams (CROs and Sponsors), and Clinical teams.
UNITYx – Multi Intake & Processing
Our Intake platform allows intake from any structured data source with a 100% accuracy rate, which means sources such as medical information, clinical cases from EDC and other quality systems can be integrated into the safety database immediately. We integrate Regulatory (L2a) cases, Partner Cases and Literature Cases from our other platforms or directly from source(s). A flexible system that brings immediate returns through reduced processing times, higher accuracy and improvement in compliance through better data visibility and tracking.
Our AI Based Triage and Case Processing Platform can process hundreds of cases in a minute, identifying main case entities, MedDRA Coding, detecting seriousness, and producing an output to integrate with any Safety Database or our UNITYx and UNITYai.Lit systems. Our platform has exceeded 98.88% in terms of accuracy against false negatives. Estimated cost savings through use is in excess of 45% for most deployments. Accuracy improvement through use of client’s previously processed data allows for acceleration of results for companies with smaller regular turn volumes.
Hosted Safety Database
We are able to provide pre-validated, deployment ready instances of the world leading safety database systems. Systems include latest features around intake integration, reporting, and workflow management – making a deployment using our packaged approach the most cost effective for small to mid-size global companies and CROs. We can provide hosted safety database through both, ARIS Global and Oracle.