DIVERSIFIED RESEARCH ASSOCIATES, LLC

Capabilities

Diversified Research Associates (DRA) provides director-level drug development, clinical research, and health program support to federal agencies and biopharmaceutical sponsors. Core capabilities include FDA/EMA-compliant regulatory documentation (IND/NDA/BLA submissions, safety narratives; clinical trial oversight and risk-based monitoring; pharmacovigilance and safety surveillance covering signal detection, aggregate reporting (PBRER/PSUR/DSUR), and benefit-risk assessment; and program evaluation with real-world evidence from claims, EHR, and registry data, including NLP analytics of unstructured records. Digital health and the intersectionality of AI and clinical development. Staff bring 25+ years across NIH (NCI, DMID, DAIDS, NINR), FDA, HHS, and industry, with proficiency in CRIS, CTDB, PTMS, CTEP-AERS, FAERS, Argus, ARISg, and Veeva Vault Safety. Past work spans 100+ NIH protocols, Operation Warp Speed, and COVID-19 vaccine authorization, delivered inspection-ready.