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.
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!
At Quanticate, and as part of our pharmacovigilance services, our highly experienced team of pharmacovigilance professionals have vast experience in several popular safety database on the market, including:
Our chosen solution that we offer as a pre-validated ready-to-go system for our customers is ‘ABCube SafetyEasy’ and each of our customers is given their own unique instance of the database ensuring that their data is segregated from other companies data and that data integrity and confidentiality is maintained at all times. This also allows our customers to have 24/7 access to the data in their database, if required.
We also support customers with PV activities such as case processing/reporting, periodic reporting and signal management who already have in place have their own system such as those other databases described above. Our experienced team are able to use these systems (subject to completion of training and SOP requirements) to process cases and report ICSRs and generate outputs for period reporting and signal/risk management activities. We can even offer support in the implementation and maintenance of these systems adhering to industry standards for computer systems validation, audit trail and data security/data integrity.
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 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 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 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’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 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.
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.
Outsourcing the setup and maintenance of your safety database will provide significant cost savings otherwise incurred if relying on an in-house built system and the expensive upgrades to keep compliance with the continuously changing regulations. Quanticate’s safety databases are validated and continuously maintained to regulatory standards thus avoiding the considerable costs of implementing, maintaining and upgrading inhouse systems.
We understand the need of customers to have oversight and feel confidence in the quality of their safety data and as such we offer the flexibility to choose a full, end-to-end case processing solution, or a hybrid approach where customers can be involved in the case processing workflow such as final quality or medical review. Each customer has their owned unique database instance, which allows secure and controlled access to customer-specific safety data and efficient maintenance of the system. This approach also allows us to tailor each customer database to meet any specific requirements the customer may have such as certain data list options (e.g. causality and severity options), reporting requirements, case narrative templates and case query forms.
Whatever stage of the product lifecycle you may be at, be it at early phase clinical trials, large pivotal late stage studies, navigating your product through authorization, dealing with complex post-authorization safety commitments and solicited sources or data and all the way through to well-established use and the seemingly endless ocean of safety data available from generic use, it is vital that you don’t let your data let you down. Ultimately, we all share the responsibility to ensure that our customers medicinal products are safe and effective for all trial subjects and patients and any safety signals are promptly identified and assessed for potential impact to the product’s benefit-risk profile. Our fully validated and comprehensive safety database, together with our team of experts and our uniquely collaborative, transparent, supportive and tailored approach ensures our customers maintained regulatory compliance and peace of mind.