Scope of Services
Clinical Trial Protocol Design
- First-in-Human (FIH) Trial Design
- Phase I Single & Multiple Ascending Dose (SAD/MAD) Studies
- Phase II Trial Design & Dosing Regimen Optimization
- Phase III Dosing Regimen Exploration
- Translational Pharmacology & ADME Studies
- Clinical Pharmacology Study Design
- Study Timing & Strategic Planning
- Customized Design by Dosage Form
- Small Molecule & Biologic Development
- Early- to Late-Stage Drug Development Support
- Clinical Pharmacology Gap Analysis & Decision Roadmap
- IND to NDA/BLA/MAA Submission Support (Briefing Books, eCTD Modules 2.7.1 & 2.7.2)
- iPSP & PIP for Phase III Programs
Pharmacokinetic Analysis
- Non-Compartmental Analysis (NCA)
- First-in-Human Dose Selection
- Allometric Scaling & Dose Projection
- Dose Proportionality Assessment
- Bioequivalence (BE) & Relative Bioavailability Analysis
- Food Effect & Drug-Drug Interaction (DDI) Analysis
- CDISC PC/PP/IS & ADaM ADPC/ADPP/ADIS Compliance
- PK Study Report & Clinical Study Report (CSR) Writing
Modeling & Simulation
- Translational PK/PD Modeling
- Population PK Dataset Curation & Exploratory Analysis
- Population PK (PopPK) Modeling & Simulation
- Exposure-Safety & Exposure-Efficacy (Exposure-Response) Analysis
- PopPK/PD Report & Simulation Report Delivery
- Mechanistic Modeling & Sensitivity Analysis
- PK/QTc Interval Prolongation Analysis
- Drug-Drug Interaction (DDI) Modeling
- In Vitro–In Vivo Correlation (IVIVC) for Biopharmaceutical Development
- Model-Informed Drug Development (MIDD) & Pediatric Dose Extrapolation Framework
Pharmaceutical Software Development
- AI-PBPK Integrated Platform
- Drug-Drug Interaction (DDI) Simulator
- Virtual Bioequivalence (VBE) Simulator
- Inhalation Formulation Simulator
- Proton Pump Inhibitor (PPI) Simulator
- Special Population Physiological Database
