The major regulators have a minimum expectation that all pharma companies will be taking a proactive approach to real-world safety monitoring. As part of this, they ideally need to employ structured statistical methods to understand the findings and their significance, in context. But now more affordable and scalable solutions are being packaged to suit all needs, transforming what’s possible.

Keeping abreast of emerging safety issues and accurately maintain a drug’s safety profile, has proved a challenge without the necessary systems and statistical expertise to model and assess the significance of findings. But this is what is expected by the major regulators as part of real-world safety signal monitoring.

For smaller pharmaceutical organisations with limited product lines, low adverse event caseloads, or established products with known safety profiles, the process of post-marketing signal detection has tended to be a manual and passive one, dependent on spreadsheets to capture any findings. In other words, signal detection has not been a particularly strategic or analytical endeavour, other than to comply with the need to report periodically to health authorities