Case Study | Device Study | Challenging Protocol Logistics

Device Study

Challenging Protocol Logistics

Sponsor

A biopharmaceutical company engaged in the discovery, development and commercialization of transcription factor decoys.

Project

A Phase 3 combined drug/device rescue study in lower limb arterial bypass graft surgery, with 80 sites and over 1400 patients. The study was still enrolling when ProTrials assumed responsibility of this rescue study. Sites had been poorly trained on the protocol and use of the device, many sites were research naive, and data monitoring was significantly backlogged.

Challenge

How do you rapidly and effectively bring up the quality of the study while developing productive relationships with the sites? Many sites were research naive so GCP training by CRAs was required as quickly as possible. The investigational product was a drug/device combination and assembly and utilization was cumbersome in the surgical setting. Surgeons had received minimal training on the use of the device. Ten ProTrials CRAs and a single Project Manager were immediately assigned. ProTrials’ highly experienced CRAs were well-equipped for the many challenging requirements of this project: conduct GCP training for site staff, receive training on assembly and administration of the device, and in-turn provide training to site staff, eliminate backlog of monitoring and ultimately beat monitoring goals.

Results

– Sites were successfully trained

– Data monitoring was completed 2 weeks ahead of schedule

– Very low query rate despite high volume of data

Sponsor Feedback

“You have done a fantastic job turning this trial into a huge operational success…

It is through synergistic teamwork that complex tasks get accomplished in record time and you are an outstanding example of that…

The work load has been tremendous, the complexity and adversity high, and yet you have persevered, problem solved and progressed…”

-Sponsor Project Manager