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Epidemiology and Biostatistics Overview and Services www.epidstrategies.com RESEARCH TRIANGLE PARK, NC | ROCKVILLE, MD © 2019 EpidStrategies, A Division of ToxStrategies, Inc. All Rights Reserved. 0219 Longitudinal study of RSV phenotypic characterization and time trends in hospitalization Cohort study of patients at high risk for CVD, including lipid- lowering therapy prescribing patterns, cholesterol levels, and CVD event rates Retrospective cohort of cold agglutinin disease patients: demographic and clinical characterization and risk of adverse events Healthcare resource utilization and costs for Medicare-insured ESRD patients with arteriovenous grafts and fistulae Critical Evaluations of Epidemiologic Data and Studies Comprehensive Meta- Analysis (CMA) ArcGIS Epi Info Software Tools Databases Used Surveillance, Epidemiology, and End Results Program (SEER) National Health and Nutrition Examination Survey (NHANES) National Death Index (NDI) The Healthcare Cost and Utilization Project (HCUP) The Health and Retirement Survey CMS (Medicare) Claims U.S. Census Bureau's American Community Survey U.S. Renal Data System (USRDS) Optum database Assistance in collaborations with proprietary client databases Study design consultation Randomization scheme design Preparation of Statistical Analysis Plans Data management, including complex data linkages Conduct of statistical analyses, including: o Linear and non-linear regression models o Multilevel models for dependent data o Pooled (IPD) analysis o Analyses of complex sample survey data Examples: Statistical analysis of cross-over trial evaluating nutritional products for glycemic control Systematic meta-analysis of arteriovenous fistulae patency Pooled IPD analysis of growth and tolerance of partially hydrolyzed whey infant formula R SAS SEER*Stat Stata EpidStrategies is founded on rigorous scientific principles that guide our research on complex health conditions. With a focus on pharmaceuticals, medical devices, nutritional products, and environmental chemicals, our scientists aid clients in the conduct, evaluation, and interpretation of epidemiological studies. Our research frequently results in peer-reviewed publications and presentations at scientific conferences and is also used in numerous regulatory documents in the US and Europe. Assisting clients in evaluating their need for epidemiological support Designing and implementing research studies Managing small and large data sets Conducting statistical analyses, meta-analyses, and pooled Individual Patient Data (IPD) analyses Conducting systematic literature reviews following established guidelines such as PRISMA, STROBE, and MOOSE Writing scientific manuscripts following the guidelines of the International Committee of Medical Journal Editors (ICMJE) Developing epidemiology sections for orphan drug applications, risk management plans, and other regulatory documents Designing, conducting, and analyzing basic clinical trials, as well as conducting post hoc analyses Providing training courses for clients in statistical software use and statistical methods and analyses Core Services Study protocol development Institutional Review Board applications Design of collaborative studies with US and international medical centers Study implementation and project management Research Study Development and Conduct Data Management and Statistical Analysis Systematic literature reviews and meta-analysis o Risk of bias for internal validity o Evaluating publication bias and heterogeneity o Sensitivity analyses Technical comments to regulatory agencies and entities, including FDA and EFSA Targeted literature reviews Evidence-based causation analyses using Bradford-Hill criteria Evaluation of study design and limitations Examples:

Epidemiology and Biostatistics · Epidemiology and Biostatistics Overview and Services PMS 363 PC C . . . . 78 M. . . . . 5 Y . . . . 98 K . . . . 24 PMS 363 C SPOT COLORS ONE COLOR

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Page 1: Epidemiology and Biostatistics · Epidemiology and Biostatistics Overview and Services PMS 363 PC C . . . . 78 M. . . . . 5 Y . . . . 98 K . . . . 24 PMS 363 C SPOT COLORS ONE COLOR

Epidemiology and Biostatistics Overview and Services

PMS 363 PC

C . . . . 78M. . . . . 5Y . . . . 98K . . . . 24

PMS 363 C

SPOT COLORS

ONE COLOR

KNOCKED OUT

CMYK COLORS

DO NOT INFRINGE ON WHITE SPACE WHEN PLACING LOGO.

www.epidstrategies.comRESEARCH TRIANGLE PARK, NC | ROCKVILLE, MD

© 2019 EpidStrategies, A Division of ToxStrategies, Inc. All Rights Reserved. 0219

Longitudinal study of RSV phenotypic characterization and time trends in hospitalization

Cohort study of patients at high risk for CVD, including lipid-lowering therapy prescribing patterns, cholesterol levels, and CVD event rates

Retrospective cohort of cold agglutinin disease patients: demographic and clinical characterization and risk of adverse events

Healthcare resource utilization and costs for Medicare-insured ESRD patients with arteriovenous grafts and fistulae

Critical Evaluations of Epidemiologic Data and Studies

• Comprehensive Meta-Analysis (CMA)

• ArcGIS• Epi Info

Software Tools

Databases Used• Surveillance, Epidemiology, and End Results Program (SEER)• National Health and Nutrition Examination Survey

(NHANES)• National Death Index (NDI)• The Healthcare Cost and Utilization Project (HCUP)• The Health and Retirement Survey• CMS (Medicare) Claims• U.S. Census Bureau's American Community Survey• U.S. Renal Data System (USRDS)• Optum database• Assistance in collaborations with proprietary client databases

• Study design consultation• Randomization scheme design• Preparation of Statistical Analysis Plans• Data management, including complex data linkages• Conduct of statistical analyses, including:

o Linear and non-linear regression modelso Multilevel models for dependent datao Pooled (IPD) analysiso Analyses of complex sample survey data

Examples: Statistical analysis of cross-over trial evaluating nutritional

products for glycemic control Systematic meta-analysis of arteriovenous fistulae patency Pooled IPD analysis of growth and tolerance of partially

hydrolyzed whey infant formula

• R• SAS• SEER*Stat• Stata

EpidStrategies is founded on rigorous scientific principles that guide our research on complex health conditions. With a focus on pharmaceuticals, medical devices, nutritional products, and environmental chemicals, our scientists aid clients in the conduct, evaluation, and interpretation of epidemiological studies. Our research frequently results in peer-reviewed publications and presentations at scientific conferences and is also used in numerous regulatory documents in the US and Europe.

• Assisting clients in evaluating their need for epidemiological support• Designing and implementing research studies• Managing small and large data sets• Conducting statistical analyses, meta-analyses, and pooled

Individual Patient Data (IPD) analyses• Conducting systematic literature reviews following established

guidelines such as PRISMA, STROBE, and MOOSE• Writing scientific manuscripts following the guidelines of the

International Committee of Medical Journal Editors (ICMJE)• Developing epidemiology sections for orphan drug applications, risk

management plans, and other regulatory documents• Designing, conducting, and analyzing basic clinical trials, as well as

conducting post hoc analyses• Providing training courses for clients in statistical software use and

statistical methods and analyses

Core Services

• Study protocol development• Institutional Review Board applications• Design of collaborative studies with US and international medical

centers• Study implementation and project management

Research Study Development and Conduct

Data Management and Statistical Analysis

• Systematic literature reviews and meta-analysis

o Risk of bias for internal validityo Evaluating publication bias and heterogeneityo Sensitivity analyses

• Technical comments to regulatory agencies and entities,including FDA and EFSA

• Targeted literature reviews• Evidence-based causation analyses using Bradford-Hill criteria• Evaluation of study design and limitations

Examples: