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CRScube Inc.
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  5. cubeSAFETY - Personnel, Processes and ...

cubeSAFETY - Personnel, Processes and Management Systems

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Pharmacovigilance requires a lot of resources such as personnel, processes, and management systems. cubeSAFETY® streamlines the Pharmacovigilance Reporting process; all the while being compliant with the regulations of regulatory agencies such as the FDA, EMA, CDE, MFDS, and PMDA.

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drug safety
drug development

BENEFITS

  • Cloud-based System
  • Streamline workflow to manage Pharmacovigilance tasks
  • ICH E2B Compliant (R2 & R3) + Regional Implementation Guidelines
  • Warning messages are displayed in real-time when entered data does not conform to the Business Rules and Regional Implementation Guidelines (IG)
  • Export data in XML and Excel format
  • CIOMS and Sponsor Customized Report exports for individual cases
  • Real-time cubeSAFETY® Import of existing safety information data: XML (ICH/FDA/EMA/CDE/PMDA/MFDS), Excel, EDC Sync
  • Features signal detection, duplicate case check, and gateway submission functions

PV Solution based on ICH E2B guideline

  • International standard-compliant drug safety reporting system
  • Development based on GCP & 21 CFR Part 11
  • cubeSAFETY® is compliant with the Regional Guidelines for the MFDS, EMA, PMDA,CDE, and ICH in one Database
  • Real-time import, export, and gateway submission with ICSR E2B R2 & R3 XML which meets Regional Implementation Compliance

Gateway Submission

  • Report to regulatory authorities with gateway to gateway submissions
  • Check the status of submission in real-time
  • Download Acknowledge File for the submission result and check the approval/error message
EDC-Sync
  • Real-time data integration between cubeCDMS® and cubeSAFETY®
  • PV manager selects the linked data at the appropriate time and creates a case

Individual Case Report Download & Emailing

  • Download and Email Reports by case (CIOMS, E2B XML R2/R3, Sponsor Customized Report)
  • Email tracking log
Data Export & Import
  • Bulk Data Export & Import with Excel Template
  • Line Listing for SAE Reconciliation export function

Signal Detection and Duplication Check for real-time monitoring

  • Signal detection
  • Duplicate case check
Fast and convenient case data entry
  • Notation function to automatically translate entered data
  • Selectively apply raw data or translated data to be applied to CIOMS and XML
  • Checks the ICSR E2B/Regional Business Rules result in real-time to check for any entry errors
  • Automatically input frequently used information when entering a case using the Load function