Pharmacovigilance software

PvNET is a comprehensive pharmacovigilance solution with adverse event reporting, adverse drug reactions (ADR) data management and regulatory reporting of ICSR (Individual Case Safety Report) that goes beyond mere compliance.
From early development through post-marketing, PvNET helps integrating the safety information and thus, helps users to make critical decisions.
PvNET is an across-the-board drug safety software successfully audited against GMP standards, 21 CFR compliance and ICH E2B.

PvNET extensive features include:

• Work Flow which supports to segregate Data Entry, QC (Review) and Scientific Assessment/Medical Review
• Extensive data validation and cross-field validation checks - validate case files for E2B compliance
• Global Dictionary(s) Support and Dictionary Management System (MedDRA Version Management)
• Audit records for all Safety Data Management activities
• Management Dashboard: Delivers dashboard with the ability to focus on relevant domain providing users with the information to draw attention to anomalies and outliers, making it possible for them to take actions quickly
• Serious adverse events automated narrative writing & Multilingual narrative text support
• Duplicate case checking
• Centralized triage prior to full case processing
• E-mail notification of a report ready to be processed with scheduled due date
• Built-in document management system (DMS), supports versioning, storage, checkout, link docs/images to cases & exports to excel

Addon Modules of PvNET:

• Literature Automation Module
• Signal detection and Benefit-risk assessment
• Follow-up Module
• Country Inbox - Predefined rules which help users to notify respective country for submitting the case

PvNET covers the full spectrum of developing good safety case report.
The elements include:

• Flexibility to create custom data-entry forms
• Description of adverse events or disease experience
• Suspected and concomitant product therapy
• Patient characteristics and history
• Documentation of the diagnosis of events
• Clinical course of event and patient outcomes
• Relevant therapeutic measures and laboratory data
• Information about response to dechallenge and rechallenge

PvNET has been developed not only to record the adverse events but to analyze and generate various regulatory reports, such as

• E2B compliant XMLs
• CIOMS
• MedWatch
• ICH-approved periodic reports including PSURs, bridging reports and other annual reports

We ensure our clients save time and costs without compromising on quality and ensuring complete stringency.