NUES, INC
Summary
consulting, clinical trials, regulatory affairs, REMS, clinical development, Medical Scientific Affairs, Patient Recruitment, Clinical Project Management, Drug Safety, Pharmacovigilance, Medical Writing, Site Start Up, Clinical Operations Management, Quality Assurance, Phase I, II, III, IV, contract research organization, drug Development, CTMS
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Description
โข Pre-clinical Development โข Phase I-IV Trial Support โข Regulatory Affairs โข Investigational New Drug (IND) Preparation & Filings โข 510(k) โข Trial Design โข Biostatistics โข Medical Writing & Communications โข Site Monitoring โข Compliance Audits โข FDA Readiness Audit โข Risk Management โข Patient-focused Recruitment โข SOP Development & Implementation โข Risk Evaluation and Mitigation Strategy (REMS) โข Pharmacovigilance โข Site Management โข eCTD Dossiers & Publication โข Computer-aided Drug Design (CADD) โข Pharmacokinetics & Pharmacodynamics (PK/PD) โข Drug Metabolism and Pharmacokinetics (DMPK)
