During the initiation of a COVID-19 trial, both Biorasi and our clinical research partner were made aware that a stray sentence from a different Phase II study protocol was accidentally included in the Phase III protocols. While a documentation deviation was easy to complete, the potential delay of further treatment to study patients was more critical. Biorasi’s QA department worked together with our partner’s QA team and found a timely solution so that enrolled patients would not miss any stage of their treatment. Additionally, Biorasi integrated additional oversight and training to confirm patient safety throughout the rest of the trial.

As one of our partners was getting ready to file an NDA for the next step of their trial, our QA team noticed that something was missing. One of the clinical sites involved, who had delayed completing their documents, had not yet filed the information needed to move forward. Biorasi’s QA team worked together with our sponsor to execute a solution to move the trial forward. We quickly activated one of our CRA resources to assist the site in coordinating and completing the missing files, and we were able to meet the study milestone without any delays.

In the midst of final statistical analysis, significant trends were observed by the Biorasi QA team. It was discovered that the data was skewed because one of the clinical sites did not use the standardized pain scale for the trial correctly. Biorasi notified the sponsor immediately and began working on a solution so that the data could be aggregated along with the other clinical sites’ information. The Biorasi QA team was able to enlist the help of our data sciences team, comparing approved data from other clinical sites to establish the changes needed to update the pain scale metrics to the correct format in time.