SafetyDatabase
Overview
SafetyDatabase is an advanced web-based application designed to meet both regulatory and operational needs in the field of clinical pharmacovigilance. It was created to support sponsors and CROs in managing Serious Adverse Events (SAEs), in compliance with European regulations (CT-3) and international Good Pharmacovigilance Practice (GVP) standards.
Each registered event is assigned a unique identifier, allowing for quick and accurate access to related clinical and safety information. This ensures timely availability of critical data throughout the entire study lifecycle.
Core Features
One of the key strengths of SafetyDatabase is its multi-sponsor management capability. Once authenticated, users can access a sponsor-specific workspace, making the system ideal for CROs handling multiple studies simultaneously.
The platform supports automatic data acquisition from various sources, including REDCap and custom eCRF systems, structured Excel files, E2B XML documents, and even email messages. This feature significantly reduces manual entry errors while improving overall data consistency.
Special cases such as pregnancies during clinical trials or second primary malignancies (SPM) are managed in dedicated sections of the platform, ensuring proper separation from standard SAEs.
All system activity is recorded in a comprehensive audit trail. Every action—whether it’s a creation, modification, or approval—is logged with user details and timestamps. Final approvals can include electronic signatures, ensuring full compliance with FDA 21 CFR Part 11 requirements.
Benefits for Sponsors
By adopting SafetyDatabase, sponsors can ensure full compliance with regulatory standards, enhance data quality through traceable and centralized management, reduce risks thanks to continuous oversight, and streamline workflows with automated processes.
Technology & Security
Built with modern and secure web technologies, SafetyDatabase places a strong focus on the protection of sensitive health data. The platform can be hosted either on-premise or in the cloud and is fully compliant with GDPR for the management of personal and medical data.
Conclusion
SafetyDatabase is a reliable partner for sponsors and CROs seeking a structured, compliant, and secure approach to pharmacovigilance. It offers a strategic solution for managing clinical safety data efficiently and responsibly.