cubeRBM

cubeRBM is a real-time monitoring solution that can improve the quality of clinical data and cut costs through risk-based monitoring. Risk-based monitoring is the process of ensuring the quality of clinical trials by identifying, evaluating, monitoring and alleviating the risks that may affect the quality and safety of clinical trials. cubeRBM collects the risks of each institution participating in the clinical study in real-time through the EDC and evaluates and compares it with a unique index called SPI (Site Performance Index score). The data collected through cubeRBM is provided via visualized graphics, allowing users to identify clinically challenging clinical institutions through formal indicators and overcome 100% SDV realistic problems.

Advantages of cubeRBM

Interoperation with cubeCDMS enables remote monitoring and central monitoring based on risk by institution.
Real-time update on Risk-Based-Monitoring report based on eCRF data.
Risk-based system SDV helps reduce on-site monitoring costs and improves data quality.
Supports visualization of various graphics, easy to grasp trends by each organization, supports real-time output of weekly reports, and does not require external editing of monitoring data.
Customizable risk indicators for each study.

KEY FEATURES & BENEFITS

Provide standardized risk indicators in conjunction with cubeCDMS.

  • TransCelerate's 16 risk indicators are categorized into categories and three types of evaluation methods are provided for each indicator.
  • Real-time collection of risk figures through interoperation with cubeCDMS.
  • Predicting trends for each organization through risk indexes calculated by the system.

Customized risk indicators enable study-specific RBM implementation

  • Can be individually configured such as the width of the risk indicator according to the task.
  • Specify risk evaluation elements for eCRF items.

Output various Graphical information and Periodical reports

  • Provide various graphic information according to SPI risk assessment index.
  • Weekly report with risk score, trends and analysis of studies. SPI score analysis report & category risk analysis report are supported.

INTERGRATED SOLUTIONS

  • Study-specific risk indicators are configurable.
  • Provides real-time analysis of collected data of cubeCDMS to calculate institutional SPI (Site Performance Index score), ranking and predicted risk scores.
  • Protocol compliance monitoring through EDC's protocol deviation check function.

AT-A-GLANCE

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