HEALTHY NORMAL VOLUNTEER – PROJECT MANAGEMENT AND SITE MONITORING

Bright Pharmaceutical Services, Inc. partnered with a top ten pharmaceutical company to manage and monitor a phase I 400-patient single-site healthy normal volunteer trial in the US.

Goal:
Bright provided a four-person monitoring team to bring in the data on time. Several of the monitoring visits lasted a full week on-site while the study was being performed in cohorts. Initial dosing visits were overseen by a lead CRA and the Project Manager oversaw the monitoring workflow and the many vendors utilized for the trial. Bright monitors reviewed data while patients were in the trial and caught data entry errors early so that those issues weren’t duplicated later on. The monitors supported and coached the study team at the site and worked directly with the PI, study coordinators and the data entry team. The Bright Project Manager oversaw all vendor activities as well as the monitoring workflow and regulatory submissions.

Outcome:
Enrollment was met on time and the electronic data was collected seamlessly with minimal queries. The Bright team remained consistent throughout the trial which was especially helpful that the sponsor had two management changes and one data manager change during the trial. The consistency of the Bright team helped serve the sponsor and the site so well that the same Bright project manager and monitoring team was assigned their next phase I trial at that same site.