Premier Research has recently supported an orthopedic device manufacturer from concept to successful CE Mark application and market clearance in Europe for their novel spine disc replacement device.
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. Our start up team successfully achieved ethics and authority approvals in a timely manner.
Once accepted by the Notified Body, Premier Research assisted the manufacturer in developing the appropriate investigators’ brochure, clinical trial protocol, patient informed consent and CRFs.
Site Selection and Contract Negotiation
The trial management group then performed contract negotiations with the sponsor-selected centers in the UK and Germany. Premier Research was also involved in developing the training program for both the device and study, supported the sponsor in finding appropriate surgery training locations and organized the cadaver training.
The sites were initiated and trained by our monitors (CRAs) in cooperation with the sponsor. Experienced CRAs also provided technical support to the sites during surgery, being there during the first interventions through until a satisfactory experience level of the surgeons was reached.
Proactive project management, progress tracking and monitoring were provided throughout the study, keeping close contact with the sites and sponsor.
Since the two centers did not meet the enrollment expectations of the sponsor, Premier Research suggested adding another center from Premier Research’s experience database. After a prompt site initiation, the new study center effectively enrolled the number of patients necessary to meet the desired timeline.
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 ultimately gained market clearance of this novel device.