POST-MENOPAUSAL WOMEN - PROJECT MANAGEMENT & SITE MONITORING - PK AND SAFETY/TOLERABILITY TRIAL

Bright Pharmaceutical Services, Inc. partnered with a Top 10 pharmaceutical company to manage and monitor 2 investigative sites in the U.S. for a 120-subject Phase I trial which aimed to understand the safety and tolerability and PK profile of single escalating and multiple doses of an investigational compound delivered intravenously in post-menopausal women.

Goal:
Manage and monitor the investigative sites and ensure that the data was being entered on the electronic data system quickly and accurately.

Outcome:
Bright was tapped to support this trial due to our rapid startup and tried and true monitor commitment. Our team remained on the trial throughout the duration. We also supported an unplanned Interim Analysis and a couple of urgent same-day data review needs . The sponsor requested that Bright team for other trials and praised us for our responsiveness and flexibility and team approach.