Pharmacovigilance, Drug safety and E2B electronic Adverse Event reporting - PvNET

PvNET is an Adverse Event Reporting software and comprehensive Pharmacovigilance software solution for Adverse Events (AEs) Case Data Management and Regulatory reporting in Pharmaceutical industry.

The software can be used by medical device manufacturers, pharmaceutical manufacturers, Marketing Authorisation Holders (MAHs) and contract research organisations (CROs) to collect, codify, scientifically assess and electronic/non-electronic reporting to Competent Authorities (CAs) or Regulatory Agencies such as US FDA, EMEA, MHRA and others. PvNET helps life sciences organisations (CROs, Pharmaceutical, etc.) to stay in regulatory compliance with various agencies.

PvNET, Adverse Event Reporting software has been developed not only to enter the Adverse Events but to analyse and generate various regulatory reports like ICSR, CIOMS, PSUR, Line Listing Reports, etc. for submission, which are according to the ICH E2B, 21 CFR Part 11 guidelines and specifications. Also, it notifies and alerts the user for timely submission of various reports.

Salient Features:

• Web based, easy to use intuitive interface
• Scalable high performance system with advanced technology
• Fully documented and regulatory compliance
• 21 CFR compliance for access control and full audit trail
• Electronic reporting of ICSRs based on ICH E2B specification
• Supports codification of MedDRA, WHO DD
• CIOMS and CIOMSII Line Listing, MedWatch Generation
• Nullification and duplicates tracking
• Dash board support and alerts to achieve deadlines
• E2B Compliant XML export and import
• Auto-narratives based on case data
• Produce preloaded templates for PSUR submissions requirements for post marketing Pharmacovigilance
• Work Flow support to segregate data entry, QC (Review) and Scientific Assessment/Medical Review
• Reports for Signal detection and line listing available

 

Modules:

• Management of Safety Data Standards
• Global Dictionaries Support: Drug (i.e., WHO-DD)
• Global Dictionaries support: Adverse Reactions (i.e., MedDRA)
• Multiple Versions of MedDRA and Advanced MedDRA Browser
• ICH E2B Based Reference Libraries: Country, Dosage, UOMs
• Automated linking of fields to reference library
• ICH E2B compliant fields and field specifications
• 21 CFR part 11 compliant access controls and audit trails
• Online reference for E2B and Volume 9A guidelines
• Individual Case Processing for Adverse Events
• Case Creation: Data entry and import
• Centralised triage before full case processing
• Automated case creation with E2B XMLs and ASPERs PDF
• Multiple format support for in-bound safety data
• Search and Tag duplicates
• Advanced case search on multiple search conditions
• Integrated Workflow engine and Task/Alert dashboard
• Case versioning and complete case life cycle
• Automatic Narration authoring (English)
• Multiple language narratives
• Attachment of source/other documents and images
• Management dashboard for work status and team productivity
• Global Submissions and Periodic Reports
• CIOMS, Medwatch and E2B (XML) for ICSR
• Online exchange of ICSRs and SUSARs with regulatory agencies
• Periodic line listing and tabulation summaries
• Readymade PSUR template with periodic data
• PADER Report for US
• Complete tabulation for signal detection and report writing