Proper data collection insures robust dosimetry calculations. Drawing on significant experience in regulatory approval, CDE can help develop study protocols to collect the right image and excretion data. This greatly lessens the likelihood of expensive and time consuming repeat studies. Proper data collection insures that accurate and regulatory compliant data sets are obtained.
CDE can help you design your image collection protocol, assisting with details such as matrix size, field of view, image standards, transmission scans, phantom studies, and temporal spacing of image collection times. Costs need to be contained, yet sufficient collection of data is important to achieve regulatory compliance. CDE can help you decide how many images to collect, and the appropriate times for collection to minimize costs, maximize patient and study personnel convenience, yet insure adequate data collection.
CDE can help you to decide what and how excreta, blood, and other samples should be collected, and the appropriate temporal sequence for this collection. CDE can help you address such issues as dynamic vs static imaging, scan speeds, and other dosimetrically relevant imaging issues. CDE can also provide you with assistance in the dosimetry and regulatory impacts of drug or isotope formulation changes, and help you design a dosimetry equivalence bridging study.
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