Case Study

Strict Processes Rescue Complex MS Trial

Source: Biorasi
Case Study - Strict Processes Rescue Complex MS Trial

A specialty pharmaceutical company engaged Biorasi to rescue their phase 2 clinical trial for treatment of spasticity caused by multiple sclerosis (MS). The incumbent CRO was not meeting enrollment expectations and a further delay by the contracted distribution depot was causing the study to miss key milestones that would prevent timely submission of the clinical study report (CSR). At the current rate, delivery of the CSR would be completed one year later than original projections. Biorasi was tasked with the aggressive goal of enrolling twenty patients in two months using a limited number of sites. Clinical trials in MS are already challenging due to an incomplete understanding of the pathophysiology of the disease and finding patients to participate in MS trials can be tricky, especially with such a tight time constraint. What was needed was an innovative solution that could be implemented immediately, and executed efficiently without putting quality at risk. Read how Biorasi’s project management-first approach allowed rapid feasibility and site startup to meet critical deadlines.