Description

Metrum Research Group LLC We are a leading provider of biomedical modeling and simulation services in the U.S.A. and internationally. Founded in 2004, we have worked with over 75 clients on more than 200 projects and more than 30 regulatory filings. Our experience spans R&D efforts for small molecule pharmaceuticals, biologic therapeutics, diagnostics, and medical device/drug-device combinations, across multiple therapeutic areas. We provide contract research focused on enhancing knowledge building in biomedical research and development through quantitative modeling and simulation. Our services include strategic modeling and simulation for R&D decision support and in silico optimization of clinical trial designs, model-based data analysis, and regulatory report preparation as well as general consulting in the areas of biostatistics, pharmacokinetics, pharmacodynamics, clinical pharmacology, pharmacometrics, clinical trial design, and modeling and simulation systems/software qualification. Technical guidance and support services for clients undertaking their own quantitative modeling and simulation projects is also offered. Our areas of expertise include Bayesian modeling and simulation for decision support and trial design evaluation, population PK and PK-PD analyses, disease progression modeling, model-based meta analysis of therapeutic area data, optimal study design for PK-PD, physiologically-based and systems biology modeling, exposure-response or dose-response modeling of biomarkers, clinical outcomes and adverse events, clinical trial simulations, and post-marketing data analysis. We are committed to growth of the science of modeling and simulation within collaborating institutions and full transfer of knowledge to our clients. Our standard modeling and simulation project deliverables include all data assembly and analysis code, modeling output, graphics and modeling run logs; quality control logs and data definitions files; draft and final reports with supporting electronic appendices; and technical review sessions with client scientists.

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