Interventional Cardiology/Electrophysiology CE Mark Trial

Premier Research has recently supported an electrophysiology device manufacturer from concept to successful CE Mark application and market clearance in Europe for their novel ablation catheter device.

Medical Writing
Once accepted by the Notified Body, Premier Research assisted the manufacturer in developing the appropriate investigators’ brochure, clinical trial protocol, patient informed consent and CRF.

Data Management and Statistics
Premier Research wrote the data management plan, built the database for this project using Oracle-based remote data capture system and trained all the sites involved prior to recruiting the first subject. The sites were selected based on their expertise in this area, and all sites were needed to ensure successful patient recruitment for this study. One site, however, had never been involved in electronic data capture studies, and their IT department had restriction on internet access. Premier Research’s Helpdesk and Technical Operations departments worked with the hospital’s IT department for several days to resolve this issue. The only possible solution however had to be submitted to the hospital board for approval but as the board was not meeting for a few weeks and first subject in was imminent, Premier Research decided to solve the problem permanently by providing a laptop and wireless dongle to the investigator for the duration of the study. A Premier Research statistician provided support in protocol design, wrote the statistical analysis plan and provided the listings and tables for the interim and final reports.

Start-Up
The successful program began with our strategic consulting team, in close collaboration with the client’s product experts, developing a strategy during the early stages of product development. Further, we assisted in the selection of a Notified Body, presentation of the technical data and proposed the clinical and regulatory plan to the Notified Body in order to validate the clinical trial regime and demonstrate early compliance with the appropriate EU essential requirements, involving post marketing surveillance already into a CE Mark trial protocol. Our start-up team successfully achieved ethics and authority approvals in a timely manner.

Site Selection and Contract Negotiation
The trial management group then performed site qualification and contract negotiations with the sponsor-selected centers in five European countries including Germany, Czech Republic, France, Monaco and Switzerland. Premier Research was also involved in developing the training program for the study.

Site Initiation
The sites were initiated and trained by our monitors (CRAs) in cooperation with the sponsor. Selected, experienced CRAs also provided technical support to the sites during interventions, supporting the sponsor in dedicated technical data collection.

The Cath Lab and indication experience of Premier Research CRAs was an added value for this project, improving the relationship to 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 those, closing the database in time for a six month interim analysis. Premier Research medical writers wrote the interim report that served for presenting the study data to the notified body for successfully achieving the CE Mark.

Safety and Compliance
Premier Research’s dedicated medical device safety officer continuously monitored patients’ safety and reported any reportable event to the regulatory authorities. The safety officer was involved in preparing data for the clinical events committee as well.

Conclusion
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 ultimately gained market clearance of this novel device.

After successful performance in this trial to the full satisfaction of the client, Premier Research was awarded to perform full services for the US-IDE trial of the same device, supporting the study in the US and Europe.

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