Management of Multiple Phase 3 Trials

Ophthalmology Study

Management of Multiple Phase 3 Trials

SPONSOR

A world renowned leader in the biotechnology industry

PROJECT

A Phase 3b ophthalmology study of an experimental treatment for Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) targeting up to 5,000 adult patients age 50 and above. ProTrials was contracted to initiate, manage and monitor this 145 center study. We were given two months from contract initiation to enroll the first patient.

CHALLENGE

How do you rapidly scale up and effectively launch a large Phase 3b study in addition to managing two ongoing Phase 3 AMD studies for the same sponsor? ProTrials quickly developed a study management team that divided activities into digestible components. A Lead Project Manager was assigned to act as the primary contact with the Sponsor and direct the other managers on the team. A vendor manager was given the task of starting up and managing all associated vendors (e.g., central reading center). A regulatory site manager was given the task of managing all site-related and central IRB related documents and ensuring timelines were met. A Lead CRA was assigned to manage all site related questions, as well as all monitor related questions, and to post questions/answers in a centralized document. Lessons learned were shared across all three teams in a timely manner. Tools and processes were streamlined across all the teams to ensure consistency and efficiency.

RESULTS

First patient was enrolled on schedule and the study was fully enrolled as planned. In addition, 313 extra patients were enrolled due to the popularity of the experimental treatment – all within eight months. The other two Phase 3 studies did not miss any goals or slip on timelines and remained on budget. These studies resulted in the successful BLA approval for this important AMD treatment.

SPONSOR FEEDBACK

“ProTrials did a phenomenal job staying on target throughout the project and was able to scale up quickly and efficiently during a challenging startup effort.”

-Sponsor project manager.