A Patient-Centric Approach Rescues Complex TBI Study

Site selection is one of the most crucial parts of planning a study. Ensuring that sites are performing up to par while a trial is underway is equally important but often neglected. Biorasi was asked to assist in a phase II trial of stem cell therapy for traumatic brain injury (TBI). Challenges included a complex surgical procedure, variability introduced by subjective rating scales, and a convoluted patient journey from enrollment to completion. That convoluted pathway was posing severe problems especially for enrollment: patients were calling sites that had not yet been activated, sites were not properly following up with patients to make sure they were screened, and candidates were being lost between screening and assessment sites. Even though the sponsor knew a rescue was in order, they were hesitant to rely on a new CRO for help.

Read how Biorasi acted as a study navigator and facilitated communication between participants and sites and personally took measures to follow up with participants who would have been otherwise lost between screening visits.