Biorasi recognized the sponsor’s hesitance to engage with a new CRO and offered a limited engagement option to test the waters. In this “study navigator role,” Biorasi coordinated with the incumbent CRO and was able to thoroughly train while gradually assuming responsibility of the study. As study navigator, Biorasi facilitated communication between participants and sites and personally took measures to follow up with participants who would have been otherwise lost between screening visits. Initial results were so positive that Biorasi was asked to entirely replace the incumbent CRO in managing the trial. The takeover included the following:
- Replacing multiple project managers with one single contact to improve communication
- Adding new sites and tossing underperforming ones
- Increasing site booster visits
- Creating a new vendor manager position to adapt to the study’s needs
- Incentivizing investigators for database review to identify more potential participants
Biorasi’s prior experience with trial rescues allowed for a quick and organized transition. The trial saw an immediate increase in the number of screenings and was even able to overrecruit by about 10%. Patients no longer complained of the “poor customer service” that they experienced before the rescue. Efficient data collection and management strategies ensured that the later phases of the trial would be streamlined, setting the trial back on track to meet the original deadlines even though it had fallen so far behind.