Premier Research 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.
A very experienced Premier Research start-up team was involved in activities planning from the first days of involvement. This permitted for thorough planning of all submissions which included 12 countries and allowed Premier Research to provide its experience and expertise in the EC and CA submission process. Thanks to Premier Research’s knowledge of local requirements, the team was able to accomplish the submissions timely and effectively.
The Premier Research project management team was highly involved in developing study specific forms and logs supporting the sponsor’s requirements and needs. The Project Manager and Clinical Manager were actively involved in the preparation and development of training presentations that were used during the site initiation visits. The sites were initiated and trained by our monitors (CRAs) in cooperation with the sponsor.
Proactive project management, progress tracking and monitoring were provided throughout the study, keeping close contact with the sites and sponsor.
Timelines were challenging for such a study design (all-comers / 2300 patients) but Premier Research was able to achieve those, closing the database in time for the 12 and 24 month interim analyses.
A very experienced and dedicated CRA team provided the highest quality monitoring for the 19 activated sites. Continuous training ensured top level performance of monitoring activities. At the same time, great interpersonal skills and strong relationships with the sites and investigators allowed maintaining a high compliance with the study requirements from the sites. Continuous site supervision from the CRAs kept the enrollment rate high as well as provided for top quality clinical data.
Local CRAs were involved to provide fast site access and limit travel time and costs.
Premier Research’s dedicated medical device CEC coordinator continuously monitored patients’ safety and CEC events entered in the CRFs in cooperation with the monitors and sites. The CEC coordinator reviewed the source documentation provided by the monitors before they were sent to be translated and included in the full CEC package to the clinical events committee for review.
Progress CEC tracking was provided throughout the study and discussed on a regular basis with the Sponsor and involved third parties.
As best evidences of the study conduct success, the 12 month data was presented at international cardiology congresses, and the 24 month data is going to be published in The Lancet journal.