What is a Pharmacovigilance Safety Database?
A pharmacovigilance safety database is the central repository for individual case safety reports or ‘ICSRs collected for a company’s medicinal product(s) from all sources globally. It is vital that any pharmacovigilance safety database is kept up to date with the latest regulatory requirements and validated to meet both international standards and business requirements. This is because safety databases facilitate the reporting of individual and aggregate safety data to authorities and third parties and provides key information for the detection of safety signals and the ongoing evaluation of the risk-benefit profile of the company’s product(s).
There are a number of commercial off the shelf pharmacovigilance safety database solutions available and all can present significant savings in cost, resource and time to the alternative of the development of in-house solutions, not to mention the obvious advantages of taking a system that has been ‘tried and tested’ but many other companies in the industry.
AB Cube: SafetyEasy
AB Cube SafetyEasy is 21 CFR Part 11 / Eudralex Annex 11 and ICH E2B(R3) compliant-ready multivigilance database. With its fully integrated platform of tools and functionality, it offers comprehensive and versatile safety data management via a clear, intuitive and user friendly interface. SafetyEasy comes with inbuilt query and reporting functionality providing validated outputs designed for expedited and periodic reports as well as signal detection and case management. Data is checked for errors and missing data by the system at point of entry and on case save according to mandatory data elements and ICH E2B business rule validation checks. The system is delivered as a cloud based software-as-a-service (SaaS) solution as is regularly updated to meet current regulatory standards and industry requirements.
Quanticate's Opinion:
Defining features for AB Cube SafetyEasy are its no-nonsense and easy to use user interface, integrated functionality, and ease of data migration both into and out of the database.
Oracle: Argus Safety Database
Oracle Argus is a market leading pharmacovigilance database. The main features of Argus database include global case processing, signal detection, detailed analytics, electronic case intake and electronic expedited reporting in both E2B(R2) and E2B(R3) formats, risk management, periodic reporting and submissions; as well as the capacity to hold large volumes of cases.
Quanticate's Opinion:
Defining features for Oracle Argus safety database include its long history in the pharmaceutical industry, brand awareness and configuration options. It is one of the more complex systems available and therefore we feel better suited to large pharma companies with high volumes as safety data and with the resources to invest in its implementation and maintenance.
Aris Global: ARISg/LifeSphere Safety
Aris Global’s LifeSphere Safety (otherwise known popularly as ARISg) is another market-leading pharmacovigilance database with a long and well-established heritage in the industry. It provides comprehensive suite of functionality and tools as well as additional modules and interfaces covering other aspects of pharmacovigilance as well as regulatory, medical affairs and clinical solutions.
Quanticate's Opinion:
Defining features for LifeSphere Safety are its established popularity within the pharmaceutical industry and options for configuration and integration with our modules and systems.
Other Systems
All safety database systems including those outlined above, PV Works, SafetyBase Interchange, Veeva Safety, etc. offer the same basic functionality and data handling capabilities to support compliance in pharmacovigilance critical activities of ICSR management. The choice of the database routinely comes down to key stakeholder preference based on prior experience, cost, hosting options and compatible extra features (optional or inclusive as standard).
No one system is superior to all others, all systems seem to have their passionate followers and battle weary sceptics and the success or failure of any system may ultimately come down to the implementation, management, training and oversight of the system rather than which database solution was selected in the first place.
