Case study
Insulin pump – Diabetes type II.
D-TARGET is currently supporting a device manufacturer in a pilot – first in man study.
Start up
The D-TARGET start up team was involved in the activities planning from the first days of the company involvement. It allowed timely planning of the submissions in Austria. D-TARGET provided its experience and expertise in the EC and CA submissions where applicable. Good knowledge of the local requirements is a great advantage of the D-TARGET start up team. Thanks to this experience D-TARGET was able to complete the submission process in very efficient way and short time.
Site Selection and contract negotiation
Together with the sponsor, the trial management group selected the study center, and later the contract negotiation was also supported by D-TARGET.
D-TARGET was also involved in developing the training program for the study.
Site Initiation
D-TARGET project management team was highly involved in development of the study specific forms and logs supporting sponsor’s requirements and needs. Clinical Research Associate supported the preparation and development of the training presentations to be used during the site initiation visits. The site was initiated and trained by our monitor (CRAs) in cooperation with the sponsor.
The experience of D-TARGET CRA was an added value for this project, improving the relationship to the site.
Study management
Proactive project management, progress tracking and monitoring were provided throughout the study, keeping close contact to the site, and the sponsor. Continuous follow up on the enrollment rate, monitoring activities and study compliance prevents the project from delays and occurrence of major issues.
Clinical monitoring
A very experienced and dedicated CRA provides high quality monitoring. Continuous training assures the performance of monitoring activities. At the same time great interpersonal skills and very good relationship with the site and investigators allows maintaining a high compliance of the site with the study requirements.
Conclusion
It is with great team spirit, readiness to perform, expertise, dedication and flexibility that all members of the D-TARGET team, across many functional areas, worked together to fulfill the client’s expectations and , depending on the outcomes, will lead to CE marking of this novel device.