Services
Scientific and tech services for drug development at any phase, spanning strategic consulting, analysis and interpretation, and tech solutions.
Featured
Scientific
Clinical pharmacology
Expert guidance on regulatory and development decision-making across all phases
- Submission support
- Document authorship/co-authorship
- Regulatory meeting attendance and support
- Strategy and guidance
Scientific
Noncompartmental analysis
Reproducible, submission-ready descriptive analyses with validated domains
- Validated domain generation
- Submission-ready analyses and documentation
Scientific
Pharmacometrics
Quantitative modeling to enable informed decision-making across phases
- population Pharmacokinetic (popPK) modeling
- Pharmacokinetic/Pharmacodynamic (PK/PD) analysis
- Exposure-Response (ER) analysis
- Physiologically based pharmacokinetic (PBPK) analysis
Technology
Application and dashboard development
Custom Shiny apps and dashboards that turn complex data into faster decisions
- Shiny
- 2-day turnaround
- Dashboards
Technology
Posit Team infrastructure support
Posit Team infrastructure configured for reliable, production scale scientific work
- Posit
- Connect
- Workbench
- PPM
All services
C-QT modeling for TQT study waivers
Strategic and quantitative support for your thorough QT waiver
Clinical pharmacology
Expert guidance on regulatory and development decision-making across all phases
Clinical trial design
Integrate quantitative insights with our expertise to de-risk clinical trial design
Exposure-response modeling of efficacy and safety
Quantitative models to describe and predict your drug’s efficacy and safety
IND support
Strategic support for a smooth and successful transition to clinical trials
Mechanistic modeling (PBPK and QSP)
Bottom-up modeling integrating biological knowledge and in vitro data
MIDD Paired Meeting Program
Accelerate your development program by leveraging the FDA’s MIDD Paired Meeting Program
NDA/BLA support
Strategic and quantitative support for market authorization submissions
Noncompartmental analysis
Reproducible, submission-ready descriptive analyses with validated domains
Pharmacokinetic and pharmacodynamic modeling and simulation
Quantitative models to describe and predict your drug’s PK and resulting PD response
Pharmacometrics
Quantitative modeling to enable informed decision-making across phases
Project Optimus
Align your oncology program with the goals of FDA Project Optimus
Translational modeling for FIH dose selection
Leverage a quantitative approach to first-in-human (FIH) dose selection
Application and dashboard development
Custom Shiny apps and dashboards that turn complex data into faster decisions
Posit Team infrastructure support
Posit Team infrastructure configured for reliable, production scale scientific work
SAS migration support
Modernize SAS workflows without disrupting active studies
Support services
Responsive support options matched to the criticality of your work
Technology services
Technology solutions for scientific teams working in regulated environments
Training and enablement
Practical training that helps scientific teams build confidence and improve workflows
Validation services
Validation documentation and testing for auditable, compliant environments