Interventional Cardiology/Transcatheter Aortic Valve Trial

Premier Research has recently supported a transcatheter aortic valve bioprothesis manufacturer in a post CE Mark international study.

Start-Up
A very experienced Premier Research start-up team was involved in activities planning from the first days of involvement. This permitted for timely planning of all submissions in 10 European countries andallowed Premier Research to provide its experience and expertise in the EC and CA submission process. Thanks to Premier Research’s knowledge of local requirements, the team was able to complete the submissions in a timely and efficient manner.

During the study start-up phase, the Project Manager and Clinical Manager developed numerous tracking tools that provided detailed information regarding study progress for the sponsor. This continuous follow-up on enrollment rates, monitoring activities and study compliance prevented the project from delays and occurrence of major issues.

Site Initiation
The Premier Research project management team was highly involved in developing study specific forms and logs supporting the sponsor’s requirements and needs. The Project Manager and Clinical Manager supported the preparation and development of the training presentations that were used during the site initiation visits. The sites were initiated and trained by our monitors (CRAs) in cooperation with the sponsor.

The Cath Lab and indication experience of Premier Research CRAs was an added value for this project and helped support a strong working relationship with the sites.

Study Management
Proactive project management, progress tracking and monitoring were provided throughout the study, keeping close contact with the sites and sponsor.

Timelines were challenging but Premier Research was able to achieve the planned enrollment and monitoring rates. At the same time, the team maintained a high quality of performance which resulted in quality data for the project.

Clinical monitoring
A very experienced and dedicated CRA team provided high quality monitoring for the 32 activated sites. Continuous training ensured thorough monitoring activities. At the same time, great interpersonal skills and strong site relationships allowed maintaining a high compliance with the study requirements from the sites. Continuous site supervision from the CRAs kept the enrollment rate high as well as provided for top quality clinical data.

Safety and Compliance
Premier Research’s dedicated medical device quality department supported the clinical team with their experience and expertise to ensure compliance with the applicable regulations.

Conclusion
In a team approach, across many functional areas, Premier Research fulfilled the client’s expectations and obtained the anticipated study progress within given timelines.

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