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QuantifiCare - Project Management Services
At QuantifiCare, our project team members come from varied backgrounds in clinical and scientific research. Our qualified staff consist of Imaging Specialists, Project Managers, Data Managers, Trainers, QA Specialists, all working together as a cross-functional team to understand your trial requirements and consult on the latest imaging techniques. We have developed both internal SOPs and adhere to world class regulatory standards which are in accordance to FDA 21CFR Part 11, EMA and other national regulatory .
In the trial set-up phase, our cross functional project team meets with the Sponsor and CRO to develop an imaging approach tailored to your study protocol requirements and deliver study-specific imaging documentation, trackers, training, and budgets to ensure expectations are met at each stage of the study.
Learn more about our Study Start-up services
During the on-study phase, the Project Leader’s primary role consists of monitoring image quality and providing guidance and support to the investigative sites via our integrated query system and unlimited hotline. Tools and trackers are maintained to allow real-time monitoring of imaging data and overall trial progression by authorized site staff, Sponsors and CROs.
During the closing phases, our team will retrieve the equipment from each investigative site and consolidate all imaging data. Each site will be provided with a record of their imaging data, and a consolidated study archive will be provided to the Sponsor. Per regulations, QuantifiCare is responsible for maintaining an archive of all imaging and patient data for a period of 15-years.