Case study
Orthopedic Trial - Spine
D-TARGET 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.
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. Our start up team successfully achieved ethics and authority approvals in a timely manner.
Medical writing
Once accepted by the Notified Body, D-TARGET assisted the manufacturer in developing the appropriate investigators’ brochure, clinical trial protocol, patient informed consent and CRF.
Site Selection and contract negotiation
The trial management group then performed contract negotiations with the sponsor-selected centers in UK and Germany. D-TARGET was also involved in developing the training program for both the device and the study, supported the sponsor in finding appropriate surgery training locations and organized the cadaver training.
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 surgery, being there during the first interventions through until a satisfactory experience level of the surgeons was reached.
Study management
Proactive project management, progress tracking and monitoring were provided throughout the study, keeping close contact to the sites and the sponsor.
Since the two centers did not meet the enrollment expectations of the sponsor, D-TARGET suggested to add another center from D-TARGET's experience database. After a prompt site initiation the new study center effectively enrolled the number of patients necessary to meet the desired time lines.
Safety and Compliance
D-TARGET’s dedicated medical device safety officer continuously monitored patients’ safety and reported any reportable event to the regulatory authorities.
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.