Premier Research is currently supporting a peripheral intervention device manufacturer in a 100 patient study being conducted in Germany under US-IDE conditions to support the FDA approval for a new indication, treating femoropopliteal artery in-stent-restenosis.
The Premier Research Project Manager and local CRAs supported the sponsor in site selection assessment and performed contract negotiations with the selected centers. Our team supported the sponsor in developing the essential documents, adapting these for local requirements, and successfully achieved ethics and authority approvals in a timely manner for the eight centers in Germany.
Premier Research was also involved in developing the training program for both the device and study. The trial master file was created and maintained by our clinical trial assistants.
Premier Research prepared the investigator files using our dedicated device forms and logs. The sites were initiated and trained by our monitors (CRAs) in cooperation with the sponsor. Our dedicated CRAs throughout Germany were allocated to the specific sites accounting for fast site access and limiting travel time and costs.
Proactive project management, progress tracking and monitoring were provided throughout the study, keeping close contact with the sites and sponsor.
Safety and Compliance
Premier Research’s dedicated medical device safety officer continuously monitored patients’ safety and reported any reportable event to the regulatory authorities.
It is with great team spirit, readiness to perform, expertise and dedication that all members of the Premier Research team, across many functional areas, worked together to fulfill the client’s expectations and successfully complete this trial.