Interventional Cardiology / DUS All-Comers Trial

D-TARGET is currently supporting a Drug Eluting Stent manufacturer in a post CE-Mark All-comers study in European countries and Israel involving 2300 patients. Study data will be used to obtain FDA regulatory approval.

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 planning all the submissions in 12 countries. D-TARGET provided its experience in 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 accomplish the submission process effectively, providing the sponsor with the necessary expertise.

Site Initiation

D-TARGET project management team was highly involved to develop the study specific forms and logs supporting sponsor’s requirements and needs. Project Manager and Clinical Manager were strongly involved in 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.

Study management

Proactive project management, progress tracking and monitoring were provided throughout the study, keeping close contact to the sites and the sponsor.

Timelines were challenging for such study design (All-Comers / 2300 patients) but D-TARGET was able to achieve those, closing the database in time for the 12 & 24 month interim analyses.

Clinical monitoring

A very experienced and dedicated CRAs team provided the highest quality monitoring of 19 activated sites. Continuous training assures the top level performance of monitoring activities. At the same time great interpersonal skills and very good relationships with the sites and investigators allow maintaining a high compliance of the sites with the study requirements. Continuous supervision of the CRAs over the sites keeps the enrollment rate high as well as the top quality of the clinical data.

Local CRAs are involved to have fast site access and to limit travel time and costs.
 

CEC coordination

D-TARGET’s dedicated medical device CEC coordinator continuously monitored patients’ safety and CEC events entered in CRF in cooperation with monitors and sites. CEC coordinator review the source documentation provided by Monitors before being sent to translation and provide full CEC package to the clinical events committee for their review.

Progress CEC tracking were provided throughout the study and discussed on a regular basis with Sponsor and appointed third parties involved.

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 obtain expected study progress within given timelines.

As best evidences of the study conduct success, the 12 Month data was presented to international cardiology congresses and 24 Month data are going to be published in the famous THE LANCET journal.

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