Case study
Peripheral Intervention
D-TARGET has recently supported a peripheral intervention device manufacturer in a study intending to provide data on novel indication of the device for the FDA. Study was performed with 8 sites in Germany.
Medical writing
D-TARGET assisted the manufacturer in developing the appropriate documents like clinical trial protocol, CRF and patient informed consent. Especially the latter was adapted to local EC requirements already known to our start up team to avoid needless delays.
Start up, site selection and contract negotiation
Sponsor selected sites were discussed, sharing the experience of D-TARGET on these.
The dedicated start up management group then performed contract negotiations with the agreed centers in.
D-TARGET was also involved in developing the training program for both the device and the study.
Our start up team successfully achieved regulatory approvals in a timely manner.
Study management
Proactive project and site management, progress tracking and monitoring were provided throughout the study, keeping close contact to the sites and the sponsor.
Since the enrollment in the sites that the sponsor needed to use for marketing reasons was behind the expectations, D-TARGET was able to identify additional centers that helped bringing the study back on track.
Safety and Compliance
D-TARGET’s dedicated medical device safety officer continuously monitored patients’ safety and reported any reportable event to the regulatory authorities. Our CRAs supported the sites with the local ethics committee SAE reporting.
Budget
Although enrollment took longer then expeted D-TARGET was able to efficiently manage the study without the need to update the budget.
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 successfully conclude this study. Sharing our experience and working in a real partnership approach was highly appreciated by the client.