What is a Safety database ?

Описание: 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.

Choosing the right Pharmacovigilance Safety Database
All of the commercially available pharmacovigilance databases will be compliant with the latest regulatory requirements such as ISO ICSR ICH-E2B submission, or at least claim to be, and choosing the right database for your company will depend on several important factors beyond simply achieving regulatory compliance. These factors will often include:

Costs of implementation and maintenance
Hosting models availability (internally infrastructure, third party hosting, vendor ‘cloud’ options
Prior experience (good and bad)
Compatibility and interoperability (with other systems)

Implementation costs including resources and effort required should not be underestimated, especially where robust and risk-based computer systems validation measures will be adhered to ensure the system is fit for purpose and meets both regulatory and business requirements. All systems need to be configured for business use and many systems, especially the more complex and long-established options available, have become highly configurable and ever more complex with options to create and customize workflows, report parameters, codelists and user interface behavior. Having a database with ‘all the bells and whistles’ including functionality you may never use, multiple complex and branching workflows for every type of case and dedicated data fields to capture every possible data type may seem like a good idea at first, but such systems can be difficult to validate, time-consuming to maintain and perhaps most importantly, very complicated to use, these systems may also prove problematic down the line with migration of data into or out of the database and with upgrades.

It is also worth bearing in mind that software vendors routinely market their systems as being compliant with all the latest regulatory requirements such as ‘E2B-R3 compliant’ and ‘CRF 21 Part 11 complaint’ but in reality, compliance with such regulatory standards comes only with careful setup, validation and management of the system as well as correct entry of case data. The well-used acronym of ‘GIGO’ (garbage in, garbage out) in computer science is so very relevant in the complex and intricate world of the pharmacovigilance safety database!