cubeCTMS Integrations

cubeCDMS serves as an all-encompassing electronic data capture platform meticulously designed for the efficient handling of clinical trial operations, significantly improving the data collection and monitoring process. This sophisticated system integrates complete data management workflows that include automatic identification of protocol violations, query batch management, and risk-based monitoring, all of which work together to enhance data integrity and operational efficiency. Featuring a user-friendly, no-code interface, research teams can easily develop electronic case report forms (eCRFs) from a library of over 55 pre-built forms and edit checks, leading to rapid database configurations and reduced start-up durations. Additionally, cubeCDMS is designed for user convenience, allowing for single data entry that is seamlessly shared across various integrated CRScube modules, which effectively reduces redundancy and simplifies the reconciliation process. Beyond this, it presents numerous benefits such as AI-driven medical coding support, intuitive drag-and-drop tools for form creation, multilingual support, and thorough audit trails along with change history tracking, all ensuring transparency and dependability throughout the trial lifecycle. Ultimately, this cutting-edge solution enables clinical researchers to concentrate more on their investigative efforts while refining their data management strategies, thus enhancing the overall efficacy of clinical trials. Additionally, its integration capabilities allow for greater collaboration among teams, further streamlining the research process.

cubeSAFETY is a cutting-edge pharmacovigilance solution that aids safety teams in the effective management of adverse event reporting, regulatory submissions, and case processing while ensuring compliance. It complies with ICH E2B as well as various regional reporting guidelines, enabling submissions to regulatory bodies such as the FDA, EMA, CDE, MFDS, and PMDA through specialized gateways, and it can automatically convert and format data for CIOMS and XML exports. The platform features AI-enhanced medical coding recommendations, duplication detection, the ability to import CIOMS PDF files, and dynamic dashboards for tracking submissions in real-time. Furthermore, it provides seamless integration with other CRScube modules, including cubeCDMS. Designed to improve the safety case entry process, cubeSAFETY ensures exceptional data quality through built-in validation tools and streamlines workflows to meet global regulatory standards, all while reducing manual efforts and costs. In essence, this innovative platform aspires to transform the landscape of pharmacovigilance by enhancing both efficiency and accuracy in the industry, making it a valuable asset for safety teams worldwide.