Strict Processes Rescue Complex MS Trial
Biorasi’s Project Management-first Approach Allows Rapid Feasibility and Site Startup to Meet Critical Deadlines
Biorasi kicked off the rescue project immediately and the project management team devised a strategy to complete the CSR by the sponsor’s requested deadline. Biorasi’s multi-venue neurology site database was leveraged and predictive analytics identified top performing, high quality sites with known ability to get up and running efficiently as well as consistently enroll MS patients at high rates. Additional feasibility was performed in the first week including expedited site visits to facilitate site selection. Aggressive pre-screening activities were implemented and monitored in real time to increase the number of quality candidates available to the sites. Finally, to further mitigate the time crunch, on-going data cleaning was performed so that database lock could be initiated three weeks prior to site closeout and time could be saved on statistical analysis.
The project kicked off on the target date. Thanks to our team’s creative execution strategy, nine sites were added and qualified patients were already available as soon as the sites were initiated. The sponsor’s ambitious enrollment goals were surpassed; 35 patients were screened and 34 were randomized in only 17 days, over a month before the sponsor requested. Database lock was achieved prior to the proposed deadline allowing for timely statistical analyses and submission of the final CSR. The project was successfully rescued even faster than proposed to ensure achievement of the sponsor’s goals.