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We are the global leaders in performing DXA review services for clinical trials. Experience Our team has provided DXA services on more than 100 clinical trials, including Phase III trials in:
Phantom Management Baseline Instrument Quality Control (IQC), longitudinal IQC, and cross calibration results are used to monitor scanner performance and variability over time. These data will also be used to monitor any shift or drift in scanner performance during the study and to generate correction factors (if necessary) that will be applied to the data results. We collect Instrument Quality Control (IQC)
data as part of each site's pre-study qualification. The baseline IQC data are used as the basis for monitoring scanner performance over time. Each site
should already be in possession of a longitudinal phantom (provided with their
GE Lunar/Hologic software) which they will scan frequently throughout the
study. These phantom data enable the site and WCC to monitor machine
performance over time. WCC recommends that sites submit their site survey and
their baseline IQC data to WCC before being approved to scan study patients. Cross Calibration is the comparison
of one scanner to another scanner at different imaging facilities. WCC circulates cross calibration phantom(s) to be scanned by each imaging facility during the
study. WCC generates a timeline and schedule with the most efficient route for phantom distribution to ensure smooth shipment and transition of the
phantom from one site to another. DXA Reporting Our standard reporting includes:
Web-based technology platform Study design Our experts work with sponsors to design trials which ensure high-quality results in a cost-effective manner. We collaborate with sponsors in workflow design and charter development to establish the foundation necessary to meet the sponsor's clinical trial goals. DXA Documentation We have extensive experience in preparing all documents needed for successful trials involving DXA, including site documentation, DXA procedure manuals, and DXA quick reference guides. Site Qualification and Training We have worked with more than 500 sites around the world that participate in clinical trials involving DXA. For each study, we perform equipment qualification of Hologic scanners and GE Lunar scanners for each site. We also perform baseline scanner reviews and instrument quality control. We require site training for all sites participating in a trial. Regulatory experience We have an extensive history in preparing submissions for regulatory approval by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Our Quality Management System is designed to provide the structure and controls required to support execution of the clinical study, while ensuring that processes meet current regulatory standards. Learn more |
