Pharmacovigilance software for E2B electronic adverse event reporting

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 organizations (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 organizations (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 analyze 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.

Key Features of Adverse Event Reporting Software, PVNET:

• 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 of Adverse Event Reporting Software, PVNET:

• Safety Data Management
  • ADR Entry and Search
  • ADR Management
  • Availability of all E2B specified fields
  • Case tracking/history comments
  • Case validation check
  • Additional attachments for cases like CIOMS II, email, etc.
  • Versioning of Cases
  • Support for multiple product types, including drugs, devices, vaccines and combination products
  • Integrated Drug Dictionaries Coding
  • Duplicate case checking
  • Centralized triage prior to full case processing
  • Timely and accurate receipt of safety information
  • Automatic notification/E mail alerts in case of new SAE entry in either of the systems
  • Extensive Report Functionality for signal detection

• Data Control Management
  • Built-in Data Repository system, supporting versioning, storage, checkout, configurable watermarking and redacting (removing sensitive information)
  • Scan/fax source documents, link images to cases, view images
  • Standard - Based Data Import Facility i.e., MeDRA, ADR, etc.
  • Integrated Dictionaries and Code list i.e., E2B Drug Dictionary, etc.
  • Fully Complaint to security as per international safely regulation
  • 21 CFA Part 11 Compliant
  • Multiple format support for inbound safety data
  • Integrates with any safety system
  • Reduces report preparation time by automating the authoring, editing and approval of content
  • Automatically sets deadlines and reminders for content editing

• Work Flow Management
  • Automatically initiate workflow
  • Integrated Workflow Engine and Task View
  • Integrated alerts and warnings
  • Case Routing
  • Management Dashboard
  • Enforces security controls with authentication and audit tracking

• Global Submission Management
  • Fully compliant with the regulations, directives and the general guidance related to electronic reporting of adverse event reporting
  • Support of SUSAR, ICSR, CIOMS II Reports, CIOMS Line Listings and Tabulated Summaries as well as MedWatch Reports
  • Exchange ICSR and SUSAR files with multiple trading partners
  • Automatically create E2B DTD 2.1 files in SGML and XML formats
  • Distribute backlog ICSRs, periodic ICSRs and attachments
  • Electronic Submission ICSRs via E2B
  • Electronic Submission (EMEA &FDA)
  • US Periodic