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Clinical Trials Statistics & Outcomes Research
Statistical Support for all phases of Clinical Trials
Statistical Analyst & Programming Support
PK/PD Support
Drug Safety – Demonstration of Risk vs. Benefit
Analysis of Observational Data
Incremental Cost-Effectiveness (ICE) Analysis
Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation
Anti-Drug Antibody (ADA) Assay Development & Validation
Statistics for Screening & Confirmatory Cut-Points
Preclinical Safety Testing / Immunotoxicology
Preclinical / Clinical Immunogenicity Risk Assessment & Mitigation Planning
Protein / Peptide Therapeutics & Biosimilars
LC-MS Analysis
ADME of Protein / Peptide Biotherapeutics
PK Data Analysis
Preclinical Toxicology / IND Support
Insulin / Insulin Analogues
Biosimilars / Biocomparables
Clinical Drug Development, Pharmacokinetics & Modeling, & Regulatory & Quality
Technical Writing
Clinical Pharmacology, Pharmacokinetics & Modeling
GLP Compliance – SOPs, Quality Reviews and System Validations
Audit Conduct & Responses
Regulatory Sciences
Clinical Drug Development
CMC Support
Preformulation, Formulation, & Analytical Methods Dev.
Manufacturing & Regulatory Support
Bioanalytical & Ligand Binding Assays
Ligand Binding Assays
CRO Lab Selection & Bioanalytical Life-Cycle-Management
Bioanalytical Statistics & Design-of-Experiments (DOE)
Method Validation
About Us
History
Mission
Management
Ronald R. Bowsher, Ph.D.
Rocco Brunelle, M.S.
Wendell C. Smith, Ph.D.
Fact Sheet
Rose Sekulovich, Ph.D.
Richard Bergstrom, Ph.D.
Erik Foehr, Ph.D.
Gordon Arbuthnot
Protein / Peptide Therapeutics & Biosimilars
Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation
CMC Support
Clinical Drug Development, Pharmacokinetics & Modeling, & Regulatory & Quality
Clinical Pharmacology, Pharmacokinetics & Modeling
Clinical Drug Development
Regulatory Science
Quality Compliance
LC-MS Analysis
Services Request
Immunogenicity
Immunogenicity Statistics
Risk Assessment & Mitigation
Immune Safety Testing / Immunotoxicology
Consultants
Paul Gesellchen, Ph.D., RAC
Philip Bowsher, B.S.
Ed Hacker, B.S.
Kristin Hardymon, M.A.
Shanna Northrup
Andy Sponsler, M.S.
Analytics
Consultants
IT / SAS Programmers
B2S Consulting™
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About Us
History
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Fact Sheet
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Bioanalytical & Ligand Binding Assays
Clinical Trials Statistics & Outcomes Research
Protein / Peptide Therapeutics & Biosimilars
Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation
CMC Support
Clinical Drug Development, Pharmacokinetics & Modeling, & Regulatory & Quality
Team
Management
Consultants
Clinical Trials Statistics & Outcomes Research
Bioanalytical & Ligand Binding Assays
Protein / Peptide Therapeutics & Biosimilars
Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation
Immunogenicity
Immunogenicity Statistics
Immune Safety Testing / Immunotoxicology
Risk Assessment & Mitigation
CMC Support
Clinical Drug Development, Regulatory & Quality
Clinical Drug Development
Regulatory Science
Quality Compliance
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IT / SAS Programmers
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Kristin Hardymon, M.A.
News & Publications
Daniel Wierda, MS, PhD – Regulators Taking Steps to Add Fresh Perspectives to the ICH S6 (R1) Guidance
Ronald Bowsher, Ph.D., MEMBER SPOTLIGHT AAPS NEWSMAGAZINE
Ronald Bowsher, Ph.D., ALUMNI SPOTLIGHT IUPUI
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