FDA and CERSI – DNA-HIVE

FDA and CERSI

DNAHIVE was awarded a contract by the John Hopkins University (FDA CERSI program) to develop and pilot a research infrastructure that takes advantage of EHRs and high-performance integrated virtual environment (HIVE). We developed Natural language processing (NLP) tools to leverage ‘real world’ data and advance the registry infrastructure reducing burden on data collection for prostate cancer active surveillance. The development of NLP approaches enabled active surveillance through EHRs and HIVE. It is applicable to other relevant devices and disease processes. The study was responsive to the FDA priority of developing methods and tools to improve and streamline clinical and post-market evaluation of FDA-regulated products using real-world data sources.