Patient registries provide a way within the life science industry to acquire real-world data on product performance, quality of life and segmentation. As pharmaceutical companies conduct Phase IV trials, they often start these registries as methods of data collection from trial participants. One of the focuses of this program is assuring that both commercial and medical goals are met through the use of the registry. Through use of the registry as a marketing tool as well as examining the scientific results associated with participating in the trial, sponsors will meet the goal of a good registry. An issue that will be addressed is the creation of functional registries that clinicians and patients will use to chart their progress. Without ensuring this functionality, there is very little opportunity for a successful trial. The program will address regulatory concerns related to use of a patient registry, in light of evolving HIPPA and FDA regulations impacting the industry.
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