Assured Information Systems

Electronic Reporting with PV-Works

PV-Works implements electronic reporting of drug safety data in full compliance with ICH E2B.

Overview

PV-Works enables electronic submission of adverse event data to Regulatory Authorities in accordance with their rules, expectations and formats.

The PV-Works electronic reporting functionality is maintained in line with all regulatory changes as they occur.

PV-Works E-reporting functions

PV-Works offers more than the ability to export adverse event data into the appropriate format: