Fauna Research Inc, 8 Bard Ave, Red Hook, NY 12571, US

Metrum Research Group is a leading provider of biomedical modeling and simulation services, in the U.S.A. and internationally. Founded in 2004, Metrum Research Group has 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. Metrum Research Group provides contract research focused on enhancing knowledge building in biomedical research and development through quantitative modeling and simulation. Metrum Research Group 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. Metrum Research Group is 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. Metrum Research Group is headquartered in in Tariffville CT, where our employees work and share knowledge. Our scientific staff has a broad background in quantitative analysis, pharmaceutical sciences, and information technology. Scientific staff members average more than 13 years of experience each in modeling and simulation. Our entire staff consists exclusively of full-time, salaried employees. Metrum Research Group maintains a closely managed and secure project workflow. All modeling and simulation project steps are independently reviewed for accuracy and integrity by qualified domain specialists. All electronic client communications, including file transfers, take place over secure connections, through a dedicated, encrypted project management web portal. Metrum Research Group has made significant investments in the computational and information systems infrastructure used to support modeling and simulation services. Services are executed on our dedicated, robust state-of-the-art grid, located in a world-class, secure SAS70 data center. These information systems are managed to 21 CFR Part 11 compliance. All our processes and information systems are organized under a written Quality Assurance program that has been successfully evaluated through client customer audits.