UVEITIS - PROJECT MANAGEMENT & SITE MONITORING - MULTI-YEAR PROJECT; MULTIPLE PROTOCOL AMENDMENTS; DATA VENDOR CHANGES AT SPONSOR

Bright Pharmaceutical Services, Inc. partnered with a Top 10 pharmaceutical company to manage and monitor 13 investigative sites in the U.S. for a 15-subject Phase II trial which aimed to understand the safety and tolerability of two doses of an investigational compound delivered intravenously in subjects with noninfectious uveitis.

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 complex trial which was eventually amended more than three times and had multiple interim analyses that required staff to be available on a moment's notice. Our team remained on the trial throughout the duration. The trial's interim database locks were sometimes met by visiting sites on holiday weekends. Enrollment was a challenge and Bright monitors held sites' hands, gave enrollment in-services, and took extra time training new site staff as protocol changes occurred. This trial required flexibility and great amounts of dedication which the team was recognized for repeatedly by the sponsor. The sponsor requested that Bright team for other trials and praised up for our responsiveness and flexibility.