Successful rare disease drug/device development programs require experience, expertise, and dedication. They are often fraught with challenges from designing an executable protocol to patient and investigator identification. At CTI, we have the experience required and the resources necessary to support rare disease drug/device development from the regulatory planning stage through to marketing approval. We have developed a unique feasibility process that includes peer-to-peer interaction to support protocol development, site/investigator identification, and can provide information critical to building customized enrollment strategies. In addition to offering full clinical operations services, we have the ability to provide strategic regulatory consulting, work with patient support and advocacy groups, and develop/manage patient registries.