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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
- 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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