ENDOCRINE - METABOLIC SYNDROME: PROJECT MANAGEMENT AND SITE MONITORING - TRANSFERRING THE REINS

Bright Pharmaceutical Services, Inc. partnered with a large pharmaceutical company to take over the management and monitoring of one investigative site for a 50-patient Phase III trial which aimed to compare 2 drugs' ability to manage insulin resistance and endothelial dysfunction in hypertensive patients with metabolic syndrome.

Goal:
Successfully and smoothly transfer the site to Bright staff. Manage and monitor the site during a rapid enrollment phase and bring the cleaned data in-house quickly.

Outcome:
Bright staff hit the ground running on this trial which was managed by a sponsor representative in Europe. We managed timelines and time zones with skill and diplomacy. Bright was able to save time and money by providing a local monitor who was already trained on the sponsor's SOPs. We also managed an unplanned interim analysis and several urgent data review requests by the sponsor. We brought data in cleanly and the team was requested again by the Sponsor.