SemanticBits has successfully designed, developed, tested, and delivered an enhanced version of the NCI adverse event reporting system, caAERS v2.8. The enhancements to this version of caAERS are designed to improve clinical trial participant safety by improving the quality and efficiency of pharmacovigilance monitoring and reporting. This version of caAERS improves safety through enhancements to service interfaces used to enable real-time integration of clinical trial data between the Medidata Rave EDC and caAERS. This version of caAERS also provides enhancements to the E2B(R2) mediated submission of safety reports to the NCI Cancer Therapy Evaluation Program (CTEP). This work was funded via the NCI through a development and support contract with Westat, Inc.