Clinical utility assessment by oncology specialists and clinical development strategy establishment from the early stages of drug development
Bridging the gap between clinical demand and oncology medical technologies through the scientific interpretation of translational research experts
Strategic planning for a one-stop service covering preclinical to clinical trials
Service
Clinical oncologist consulting for each cancer type
- Strategy development for accelerated commercialization addressing unmet medical needs in clinical practice
- Develop IND strategies and tailored non-clinical efficacy evaluation study designs to align with the specific stages of drug development
Non-clinical efficacy evaluation consulting
- Mechanism of action validation consulting
- Nonclinical study strategy development
- Consulting for custom-tailored efficacy evaluation model development
- Study design based on patient-derived models
Preclinical and early clinical consulting
- Strategies for preclinical GLP studies and early-phase clinical trials
- Interpretation of toxico kinetics, clinical pathology, and histopathology results
- Support for designing pre-clinical GLP toxicology study
- PK/PD modeling and simulation analysis
- Prediction of human pharmacokinetics and therapeutic effects through physiologically based pharmacokinetics (PBPK) model analysis
- Development of regulatory strategies for Chemistry, Manufacturing, and Controls (CMC)
- Pre-IND Meeting Support
- Establishment of early clinical development strategies, including first-in-human (FIH) and proof-of-concept (POC) studies
- Risk management for issues identified during the preclinical phase
- Strategy of regulatory preparation
