BREAST CANCER - PROJECT MANAGEMENT, SITE SELECTION AND SITE MONITORING

Bright Pharmaceutical Services, Inc. partnered with a small biotechnology company to identify, vet and select investigative sites for a 6-site 78-patient phase II breast cancer trial in the US.

Goal:
The principal investigators were chosen from a list of well-curated sites that the sponsor and Bright had strong relationships with. Bright vetted the sites for enrollment ability and high interest in participation. The strategy for patient enrollment was addressed prior to study start and the sites and the Bright team performed their roles from the outset with monitors providing training, coaching and consultation throughout the enrollment period. Bright monitors were able to review data while patients were in the trial and troubleshoot and coach the sites along the way. The Bright Project Manager oversaw all vendor activities as well as the monitoring workflow and regulatory submissions.

Outcome:
Enrollment was met one month early and the electronic data was collected seamlessly. Bright was able to save time and 7% off the budget by increasing remote monitoring activities and visiting sites as dictated by patient enrollment activity as well as locating monitors near the high-enrolling centers.