Adverse Event Database

DrugCard's Adverse Event Database is a pharmacovigilance software tool designed to support safety data management across the full case lifecycle — from data entry and storage to regulatory submission. It is built for pharmacovigilance teams seeking a centralized, compliant, and cost-effective solution that supports ICH E2B(R2) and E2B(R3) formats and meets regulatory requirements across the EU, US, and CIS markets.

The platform collects all essential safety data in one place, including patient details, drug information, MedDRA-coded events, timelines, seriousness assessments, and E2B files. It is optionally connectable to DrugCard's literature screening module, and its AI capabilities reduce manual data entry by extracting and structuring information from local and global literature sources.

Key Features

• Centralized data collection: All required fields are available in a single, submission-ready interface, with optional integration to DrugCard's literature screening module to reduce manual work.
• Multi-format support: Handles both E2B(R2) and E2B(R3) formats with full back-and-forth conversion for compatibility across evolving regulatory standards.
• AI-powered signal detection: Reduces manual data entry, highlights safety trends, captures and structures reports from multiple sources, and helps complete missing information from literature to support faster corrective actions.
• Data integrity: Compliant with FDA CFR 21 Part 11, with certified electronic records and signatures, and a certificate of conformity for official use across the EU, US, and CIS markets.
• Secure data management: Hosted on ISO/IEC 27001:2013 and SOC 2 Type II–certified data centers, with built-in GxP-aligned controls including user access roles, audit trails, and E2B XML handling.
• Advanced reporting and analytics: Supports CIOMS I, CIOMS II, line listings, and ADR summary tabulations, with export across multiple formats for regulatory-ready documentation and deeper analysis.

How the Workflow Operates

1. AI captures patient safety events and structures adverse event reports from multiple sources, including local and global literature, in seconds.
2. When integrated with other DrugCard modules, the system completes missing case information automatically.
3. Reports are converted into E2B(R2) or E2B(R3) formats for regulatory submission.

Benefits

• Intuitive and fast to use: The interface requires no lengthy training and integrates into existing pharmacovigilance workflows.
• Less manual work: Automatic pre-filling from literature reduces data entry effort and speeds up case processing.
• Flexible data export: Data can be exported in multiple formats to support reporting and analysis needs.
• Automated aggregate outputs: Aggregate reports are generated automatically without manual preparation.

Compliance and Regulatory Alignment

• User access roles: Role-based permissions and restricted access to support secure, compliant workflows in line with GxP requirements.
• E2B(R2/R3) XML file handling: Import, export, and validation of safety cases in both formats for regulatory reporting.
• Full audit trail: Time-stamped tracking of every action, change, and user for complete traceability.

The Adverse Event Database supports good documentation practice and GVP-aligned activity. It is hosted on certified infrastructure and carries compliance certifications applicable to regulated markets. The platform is available with a free two-week trial and can be implemented into existing pharmacovigilance systems.