Case study
Interventional Cardiology / Transcatheter Aortic Valve
D-TARGET has recently supported a transcatheter aortic valve bioprothesis manufacturer in post CE-Mark international study in 32 sites / 10 countries.
Start up
Very experienced D-TARGET start up team was involved in the activities planning from the first days of the company involvement. It allowed timely planning all the submissions in 10 European countries in advance. D-TARGET provided its experience and expertise in the EC and CA submissions. Very 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 effective way.
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. Project Manager and Clinical Manager supported the preparation and development of the training presentations to be used during the site initiation visits. The sites were initiated and trained by our monitors (CRAs) in cooperation with the sponsor.
The Cath Lab and indication experience of D-TARGET CRAs was an added value for this project, improving the relationship 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.
During the study start up phase, Project Manager and Clinical Manager developed numerous tracking tools to provide detailed information regarding study progress. Continuous follow up on the enrollment rates, monitoring activities and study compliance prevented the project from delays and occurrence of major issues.
Timelines were challenging but D-TARGET was able to achieve planned enrollment rate and monitoring rates. At the same time D-TARGET maintained high quality of performance and high quality data resulting for the project.
Clinical monitoring
A very experienced and dedicated CRAs team provided high quality monitoring of 32 activated sites. Continuous training assured the performance of monitoring activities. At the same time great interpersonal skills and very good relationships with the sites and investigators allowed maintaining a high compliance of the sites with the study requirements. Continuous supervision of the CRAs over the sites keeped the enrollment rate high as well as the high quality of the clinical data.
Safety and Compliance
D-TARGET’s dedicated medical device quality department serves to the clinical team with their experience and expertise ensure the compliance with the applicable regulations.
Conclusion
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 obtain expected study progress within given timelines.