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
Rose Sekulovich, Ph.D.
Richard Bergstrom, Ph.D.
Erik Foehr, Ph.D.
Protein / Peptide Therapeutics & Biosimilars
Immunogenicity, Immune Safety Testing, & Risk Assessment & Mitigation
CMC Support
LC-MS Analysis
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.
B2S Consulting™
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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
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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
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Bioanalytical & Ligand Binding Assays
Bioanalytical Statistics & Design-of-Experiments (DOE)
CRO Lab Selection & Bioanalytical Life-Cycle-Management
Ligand Binding Assays
Method Validation
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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