PV systems and database – How will technology shape PV

Are we overlooking technological advancements by sticking to what we know?

A Drug Safety Database is an integral part of any pharmacovigilance system. It is the repository of all MedDRA coded safety data from various sources including clinical and post-marketing SAEs, ICSRs, Aggregate Reports.

Modern Drug Safety Databases can perform many automated and real-time functions in the processing and analysis of safety data including, automated coding, automated validity and duplicate checking, automated case tracking and follow-up and automated submission. They can provide easy access to your data and you will also have the benefit of real-time reporting, dashboards and Benefit-Risk analysis.

The use of highly configurable and flexible validated cloud-based safety databases is on the rise.  They are secure, compliant, and validated systems and in alignment with ICH E2B structure.

It is true that PV is a highly regulated function, however, it is important to have efficient processes in place and reliable tools for data storage and signal detection.

Many MAHs refrain from upgrading their PV systems and software because they may not have access to an in-house IT team that offers a complete drug safety database management service including data migration, configuration, ongoing maintenance. However, if the right drug safety database is used, it will enable several automated functions that will allow efficient case intake, accurate medical assessment and regulatory reporting, leaving just the supervision of these systems to humans. This may significantly contribute to process efficiency and allow more higher order activities such as proactive signal detection to skilled human capacity.

Selection of the right tool may vary based on the MAH needs, therapy area, anticipated number of adverse events (AEs) and Adverse drug reactions (ADRs) and internal capabilities.

If you would like to make the switch to a cloud-based drug safety database or wish to continue to use your own drug safety database, we can support you with system configuration, validation, maintenance, and data migration. Talk to a Zenith PV partner today.

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