cubeSAFETY

 

Model: eClinical Solutions

Category: *CRO

Exhibitor: CRSCUBE INC.

Booth No: L629

 

Characteristic

 

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.

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

 

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