cubeCDMS Integrations

cubeCTMS is a comprehensive clinical-trial management system designed to provide end-to-end oversight of trials, from site and investigator tracking, enrollment management and visit scheduling through budget and contract workflows, milestone reporting and document control. It centralizes study operations and automates key processes so sponsors, CROs and study teams can monitor progress in real time, manage tasks across multiple studies, improve site communications and mitigate risk. With built-in dashboards, alerts and audit-ready logging, cubeCTMS supports regulatory compliance (including FDA 21 CFR Part 11 readiness) and enables stakeholders to manage trial timelines, resources and performance from one platform. The system integrates with other CRScube modules (such as EDC, eTMF, pharmacy/RTSM) to provide a unified ecosystem that reduces duplication, improves data flow and supports adaptive workflows during amendments or global roll-outs.

cubeSAFETY is a pharmacovigilance platform built to help safety teams manage adverse-event reporting, regulatory submission and case processing in a compliant, efficient workflow. The system supports ICH E2B and regional reporting standards, enables submissions to FDA, EMA, CDE, MFDS and PMDA via dedicated gateways, and automatically translates and formats data for CIOMS and XML export. It includes AI-powered medical-coding suggestions, duplication-detection, import of CIOMS PDF files, real-time submission-tracking dashboards, and full integration with other CRScube modules such as cubeCDMS. The platform is designed to streamline safety-case entry, ensure high data quality through built-in validation, and simplify workflows for global regulatory compliance while reducing manual burden and budget overhead.