cubeSAFETY

Pharmacovigilance requires many resources such as personnel, processes and management systems. This pharmacovigilance activities should be carried out by adopting a suitable computer system according to the safety regulations and guidelines such as CIOMS guideline, ICH E2 (A ~ F), E6. Experience the convenient PV solution, cubeSAFETY, that fully supports the Pharmacovigilance Report required by regulatory agencies such as FDA, EMA, and PMDA.

cubeSAFETY meets the GCP Scope's 'Computerized System' Standards: Essential features such as user rights management and audit trail are provided. Therefore, our customers could respond appropriately to audits implemented by regulatory bodies or other main contractors.
Manage the reporting period of reports by organizations.​​
Manage safety information from other drug development stages and use it as a basis for future license out process.
Minimize resources for Pharmacovigilance tasks.
ICH E2B compliant(R2 & R3) + Regional Implementation Guideline compliant.
Import your existing safety data into cubeSAFETY® in real-time.

KEY FEATURES & BENEFITS

It helps you to Meet the GCP Scope's 'Computerized System' requirement

  • Ability to manage Roles & Privileges and Audit trail.
  • Case management according to lock & review procedure

PV Solution based on ICH E2B guideline

  • Developed based on international standards for drug safety reporting system
  • Export & Import of E2B Compliant XML Report

The world's only Localized PV Solution

  • Expedited reporting management by each regulatory bodies
  • Customization of Report Form by regulatory bodies.
  • System Alarms by organizations.

Convenient EDC-Sync

  • eCRF data on cubeCDMS is synced to cubeSAFETY in real time.

Automatic generation of various reports

  • CIOMS, E2B Compliant XML(R2 & R3) and other Customized Reports.
  • Send reports immediately via e-mail

Customizable Alarm & Notification

  • System Alarm on Case registration and Imminent reporting deadline.

Signal Detection

  • Real-time Signal Analysis.

Real-time Data Migration

  • Convenient Data Migration between existing database and cubeSAFETY

Gateway Submission

  • Reporting to regulatory authorities through gateway to gateway support.

INTERGRATED SOLUTIONS

eCRF data on cubeCDMS is synced to cubeSAFETY in real time.

AT-A-GLANCE

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