Technology is transforming pharma covigilance (PV). The promise of artificial intelligence is of course one of the first things that springs to mind, and it is increasingly providing value. More mature technology solutions provide scalable, structured digital platforms to capture adverse event data at source, in multiple languages, across multiple use cases. It is also enabling direct reporting from healthcare professionals and patients with smarter digital ways for people to access, and contribute to, safety data.
The PV Problems of Today and Tomorrow
PV consumes around 10–15% of the total allocation of research and development investments in the pharmaceutical industry. COVID-19 raised awareness of the importance of PV but to ensure its continued evolution, and investment, we need to make sure it is fit-for-purpose, not just now but in the future.
In the past we have talked about a direct case-investment metric. More cases that have historically come in – and more complexity – mean we need more funds for PV. However, adverse event reports are no longer slated to increase with a CAGR of approx. 13% as we have been used to, in fact the FDA is reporting a decline from a peak of 2.3 million in 2022 to just over 2 million in 2024.1 This has implications for how we focus our investment and innovations. Instead of planning to deal with increased volumes, we need to focus on improving quality and efficiency and ideally provide savings for the organisation. As an example, we are increasingly capturing adverse event data directly from source, while legacy systems capture this in unstructured formats like emails which make it harder to process and do not ensure quality. We need structured digital platforms which can capture data at source and flow it directly to clients.





















