Case Study | Vaccine Study | Rescue from Global CRO

Vaccine Study

Rescue from Global CRO

Issue

A biopharmaceutical company focused on the rapid development of a novel immuno-oncology therapy.

Project

A multi-center double-blind placebo-controlled adaptive phase III trial of a vaccine to prevent cancer recurrence in high risk patients.

Challenge

How do you regain enrollment momentum in a large, phase III trial that suffers from poor quality oversight and broken communication pathways, coupled with lack of site engagement and confidence?

Solutions

ProTrials rapidly assigned a highly experienced PM, who visited clinical sites and worked with CRAs to identify gaps in documentation and protocol compliance. Team leadership then developed a Quality Plan, which included ongoing monitoring of key performance indicators visualized through a customized digital dashboard. In response, the Sponsor implemented changes, including additional protocol training of site personnel.

A Project Plan was established to further define and rebuild communication pathways between investigational sites, CRO staff and vendor partners. The PM promptly responded to site issues, questions and presented devised solutions.

Results

Investigational site engagement accelerated, demonstrated through a surge in the number of patients screened and enrolled, and the heightened quality of the data monitored.