Assured Information Systems

PV-Works - Drug Safety Software Specification

PV-Works drug safety software provides comprehensive data entry and reporting, full audit trail, links to Microsoft Office and image and document management. The pharmacovigilance database has been designed around the ICH E2B guideline such that every E2B data field maps to a specific database field. An electronic reporting function is included and coding to MedDRA is simple.

As part of the application, document management functionality allows source documents and images of regulatory reports to be stored and retrieved with the case itself.

Pharmacovigilance Functionality

Process-Driven Pharmacovigilance