Clinical utility assessment by oncology specialists and clinical development strategy establishment from the early stages of drug development
Bridging the gap between clinical demands and oncological innovation through scientific interpretation by translational research experts
Strategic planning for a one-stop service, covering from preclinical to clinical trials
Service
Clinical Oncologist Consulting (Cancer Type-Specific)
- Develop commercialization strategies targeting unmet medical needs
- Design IND and non-clinical efficacy evaluation strategies tailored to the drug development stage
Non-Clinical Efficacy Evaluation Consulting
- Mechanism of action validation
- Development of non-clinical study strategies
- Customized model development for efficacy evaluation
- Study design based on patient-derived models
Preclinical and Early Clinical Consulting
- Preclinical GLP studies and early-phase clinical trials strategies
- Interpretation of toxicokinetics, clinical pathology, and histopathology data
- Preclinical GLP toxicology study design and support
- PK/PD modeling and simulation analysis
- Pharmacokinetics (PBPK) modeling to predict human pharmacokinetics and therapeutic outcomes
- Regulatory strategy development for CMC (Chemistry, Manufacturing, and Controls)
- Pre-IND Meeting Support
- Early clinical strategy development, including first-in-human (FIH) and proof-of-concept (POC) studies
- Risk management for preclinical-phase issues
- Regulatory preparation strategies
