Interventional Cardiology/Stent Graft with New Delivery System

Premier Research recently supported a stent graft manufacturer with a new delivery system which already had a CE Mark. The sponsor was running the trial on its own, but realized that site compliance was not allowing for timely data entry and quality of data was not acceptable.

Premier Research was asked to give support to the investigational sites with data entry activities into the eCRF. In order to facilitate this most effectively, Premier Research provided separate CRAs to act as study nurses at the sites to support the investigators in entering data in time to the satisfaction of the client.

Conclusion
The timelines were challenging but Premier Research was able to achieve them, closing the database in time for a one month interim analysis, allowing the sponsor to keep their deadlines for publications and regulatory submissions.

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