5 Reasons To Move To Automated Safety Document Distribution

The very basis of pharmacovigilance is to detect, collect, monitor, and assess reports on adverse events from drug and biologic products. These reports can range in severity but all aim to support one thing – human safety. The distribution of safety event reports to investigator sites, ethics committees, and Institutional Review Boards (IRBs) can be challenging.  

It’s become increasingly difficult for pharmacovigilance teams to effectively track adverse events and distribute reports globally. The growing globalization of clinical research means that pharmacovigilance teams are tracking adverse events across more geographies and reporting channels than ever before. At the same time, pharmaceutical manufacturers are introducing more specialized drugs and investigational products to the market, which creates new unknowns for potential adverse events.  

This has resulted in unprecedented growth in the total number of adverse event reports received by the US Food & Drug Administration (FDA). From 2011 to 2021, the number of reports grew by nearly 200% with analysts projecting global pharmacovigilance spending will grow at a compounding rate of 11.5% from 2021 until 2028.  

The growth in adverse events puts tremendous strain on clinical operations and pharmacovigilance teams in both sponsor and CRO environments. Most notably, large sponsors or CROs with manual processes. Traditional processes that rely heavily on manual processes are labor-intensive and prone to human error—not to mention, they’re slow. All of these challenges add up to risk and unneeded effort.  

Technology can help automate much of the safety document distribution processes, speed the handling of adverse events, reduce costs, improve patient safety, and unlock growth opportunities alongside compliance. While this is reason enough for organizations to add a safety document distribution solution, it’s prudent to explore the other reasons why it makes sense for organizations to move to an automated system.