Interventional Cardiology / Electrophysiology  CE mark Trial

D-TARGET 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 Stats

D-TARGET 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 it would have been difficult for patient recruitment if any of these sites could not participate in the study. One site however had never been involved in Electronic Data Capture studies and their IT department had restriction on internet access.  D-TARGET’s Helpdesk and Technical Operations departments worked with the hospitals 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, D-TARGET decided to solve the problem permanently by providing a laptop and wireless dongle to the investigator for the duration of the study..
D-TARGET 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 selecting a Notified Body and presenting technical data and proposed the clinical and regulatory plan to the Notified Body in order to validate the clinical trial regime and to 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 5 european countries (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 D-TARGET CRAs was an added value for this project, improving the realtionship to the sites.

Study management

Proactive project management, progress tracking and monitoring were provided throughout the study, keeping close contact to the sites and the sponsor.
Timelines were challenging but D-TARGET was able to achieve those, closing the database in time for a 6 month interim analysis. Premier medical writers wrote the interim report that served for presenting the study data to the notified body for succesfully achieving the CE mark in time again.

Safety and Compliance

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

Conclusion

It is with great team spirit, readiness to perform, expertise and dedication that all members of the D-TARGET team, across many functional areas, worked together to fulfill the client’s expectations and ultimately gained market clearance of this novel device.
After succesful performance in this trial to the full satisfaction of the client, D-TARGET 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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