vDigiData | vDigiData

vSafety-PV™ is compliant to EMA and FDA regulatory requirements and is aligned to ICH ICSR (R2).

Features

Supports regulatory reports such as CIOMS, MedWatch, PSUR and DSUR as well and MedDRA / WhoDRUG coding.
Supports custom workflow, Follows regulatory compliance standard and norms.
Generates all common paper report formats like CIOMS and MedWatch.
Generate email alerts and system notifications with Basic signal detection reports and Dynamic query management.
Simple user friendly data capture screen, Faster data entry.
XML Import and Export.
Can be integrated with EDC and other systems.

An intuitive, integrated, user friendly pharmacovigilance software that manages the single point of entry, assessment and reporting of safety data related to drugs, vaccines, medical devices, cosmetics and food supplements.

It is compliant to EMA and FDA regulatory requirements and is aligned to ICH ICSR (R2).