Delivering On Rare Disease Trial Milestones During The COVID-19 Crisis

In early-2020, the start of the COVID-19 transmission led to quarantine, social distancing, and shelter-in-place orders. The result was the closure of many clinical trial sites, leading to the shutdown or delay of multiple existing and projected clinical trials.

Due to this health crisis, one of Biorasi’s key sponsors was facing delays in an ongoing basket trial for rare nephropathies, specifically the completion of two critical project milestones. These obstacles had the potential to upset the trial timeline and lead to interruptions in treatment as well as unexpected budget overruns.

Understanding the potential challenges caused by COVID-19, the Biorasi team immediately began to brainstorm and develop impact mitigations for the study. The resulting management strategy keenly focused on safety and risk, remote monitoring, timeline and milestone management, and budget management.

This case study reviews how Biorasi quickly took proactive measures to mitigate the impact of the COVID-19 pandemic and keep the study moving forward.