ALLERGIC RHINITIS - PROJECT MANAGEMENT & SITE MONITORING - RAPID START UP, MULTIPLE PROTOCOL AMENDMENTS

Bright Pharmaceutical Services, Inc. partnered with a Top 10 pharmaceutical company to manage and monitor 6 investigative sites in the U.S. for a 165-subject Phase IV trial which aimed to understand the bioequivalence and pharmacodynamics of a marketed compound in subjects with elevated IgE.

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

Outcome:
Bright was tapped to support this trial and we turned our budget and contract around and staffed the trial in one day. The study went smoothly despite protocol amendments and staff changes at the Sponsor. Enrollment was met on-time. Bright was able to save time and money by providing a local monitors who were already trained on the sponsor's SOPs and lived within driving distance of two of the sites. Not incurring hotel or air travel expenses for those monitoring visits saved the sponsor money and time. The data was brought in cleanly and we were able to lock the database on time. The sponsor requested that Bright team for other trials and praised up for our responsiveness and flexibility.