Pharmacovigilance requires many resources such as personnel, processes and management systems. These 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.|
It helps you to Meet the GCP Scope's 'Computerized System' requirement
PV Solution based on ICH E2B guideline
The world's only Localized PV Solution
Automatic generation of various reports
Customizable Alarm & Notification
Real-time Data Migration
eCRF data on cubeCDMS is synced to cubeSAFETY in real time.