Pharmacovigilance

Flex Databases Pharmacovigilance is a comprehensive drug safety database designed to support robust and compliant pharmacovigilance activities across both clinical trials and the post-approval stage. It provides an end-to-end solution for collecting, triaging, evaluating, and submitting safety data within a single, unified platform, making it suitable for pharmaceutical companies, CROs, and biotech organisations managing drug safety obligations.

The platform supports the full pharmacovigilance lifecycle through fully configurable workflows, enabling organisations to align their existing processes with the system or build new ones from scratch. Direct communication with partners and regulatory authorities is facilitated via EDI gateways, and reports can be generated in any format required by regulatory bodies. Flex Databases also leverages advanced technologies — including statistical methods, machine learning, and neural network approaches — for signal detection and management, enabling data-informed decisions on drug safety profiles.

Case Management and Workflow

• Fully configurable, embedded workflows to match organisational pharmacovigilance processes
• Multi-language input support for global operations
• Multi-tenant access for organisations managing multiple clients or projects
• Query chat functionality for internal and external communication
• Comprehensive audit trail to maintain data integrity and traceability
• Duplicate search to prevent redundant case entries
• Notifications and alerts for upcoming deadlines and required actions

Safety Data Analysis and Signal Detection

• Advanced safety data analysis using qualitative and quantitative methods
• Signal detection and management via statistical analysis, machine learning, and neural network methods
• Ad-hoc reporting tool for instant data accessibility and interpretation
• Reporting toolkit designed to support further evaluation and regulatory action

Regulatory Reporting and Submissions

• Support for CIOMS I, MedWatch 3500A, and E2B R3 compliant XML reports
• Local reporting forms available on demand
• Follow-up report management
• PSUR, PBRER, and DSUR line listings
• Summary tabulations builder for periodic safety reports
• Report calendar to manage periodic report timelines
• Submission tracker with country-specific setup of reporting timelines
• Cross-field validation to ensure E2B compliance

Coding and Data Management

• In-built MedDRA coding tool with auto-coding option
• Data export in Excel, Word, XML, and PDF formats
• E2B R3 XML import capability
• API-based data export for flexible integration

Integration and Connectivity

• Integration with EDC and clinical databases for seamless data flow
• EDI gateways for direct communication with partners and competent authorities
• API-based data export to connect with external systems

Flex Databases Pharmacovigilance is a cloud-based solution that integrates with the broader Flex Databases suite, including CTMS, eTMF, EDC, and Document Management modules. The platform is built with compliance at its core, supporting E2B R3 standards and country-specific regulatory requirements, and is trusted by clients across more than 30 countries.