Adverse Event Database

Adverse Event Software for Efficient Safety Data Management

An intuitive pharmacovigilance database that makes adverse event management simpler allowing users to enter, store, import, and export data with full ICH E2B(R2/R3) compliance. Its enterprise-level features are easy to explore and cost-effective.

Key Features of Our Adverse Event Database

Our adverse drug reaction database combines a rich feature set with an intuitive interface that requires no lengthy training. Centralized, compliant, and budget-friendly, it automates reporting about incidents occurring, strengthens risk management, and ensures fast, secure, globally accepted safety operations. Here’s what sets it apart:

Lightning-Fast Centralized Adverse Event Data Collection

An intuitively structured, submission-ready drug safety database with all required fields in one place. Centralized, instantly accessible, and optionally connected to DrugCard’s literature screening module to make data entry easier and reduce manual work.

Multi-Format Support (E2B R2 & R3)

A flexible adverse event management system that supports both E2B(R2) and E2B(R3) formats, with full back-and-forth conversion ensuring globally compliant reporting and compatibility across evolving pharmacovigilance regulatory standards.

AI-Powered Signal Detection

An AI-enhanced adverse event management solution that reduces manual data entry and eases case intake, highlights safety trends, and simplifies adverse event detection while capturing, structuring, and processing reports from multiple sources and helping complete missing information from literature to help you implement corrective actions faster.

Data Integrity

An FDA CFR 21 Part 11–compliant adverse event reporting system with certified electronic records and signatures, supported by a certificate of conformity for official use across the EU, the US, and CIS markets. So you don’t have to worry about FDA regulation.

Secure and Compliant Data Management

A fully protected adverse event reporting environment is hosted on ISO/IEC 27001:2013 and SOC 2 Type II–certified data centers, featuring built-in GxP-aligned controls such as user access roles, audit trails, and E2B(R2/R3) XML handling, and ensuring full compliance with industry standards.

Advanced Reporting and Analytics Tool

An adverse event management tool that offers CIOMS I, CIOMS II, line listings, and ADR summary tabulations enabling fast export of critical safety information across multiple formats for deeper analysis and regulatory-ready documentation.

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How Does It Work?

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AI captures patient safety events, structures, and processes adverse event reports from multiple sources (local and global literature) in seconds.

AI-Powered

If integrated with other DrugCard modules, it completes missing information.

Automated E2B Submission

It converts reports into E2B(R2/R3) formats for hassle-free regulatory submission.

Benefits of Using Our Adverse Event Detection Platform

Our adverse event management tool collects all essential safety data (patient details, drug information, MedDRA-coded events, timelines, seriousness, and E2B files) to help your team mitigate risks and explore similar incidents. AI extracts key information from literature, reducing manual entry and training time. Data exports in multiple formats support easy analysis, while automation generates aggregate reports instantly.

Intuitive & Fast to Use

An adverse event software with user-friendly interface that requires no lengthy training and integrates quickly into PV workflows, is highly convenient for healthcare professionals to use.

Less Manual Work

Automatic pre-filling from literature reduces manual data entry and speeds up case processing, making it easier to identify trends.

Flexible Data & Reporting

Export data in multiple formats for seamless integration into reports and analysis.

Automated Aggregate Outputs

Automatic generation of aggregate reports without manual preparation or extra effort for efficient risk management.

Full Compliance and Regulatory Alignment with GVP

The system that handles incident reporting supports all essential functions required for GxP activity, good documentation practice and regulatory compliance, including:

User access roles control — role-based permissions and restricted access to ensure secure, compliant workflows.
E2B(R2/R3) XML file handling — import, export, and validation of safety cases in both formats for your regulatory reports.
Full audit trail — time-stamped tracking of every action, change, and user for complete traceability.

We also care about continuous improvement to take into account all your needs and create a unique product.

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