Our top-notch practice in early phase clinical trial
increases efficiency of trial and quality of data generated.
One-Stop Win center in Korea for data generation & data analysis in drug development!
Need a quantitative evidence and documentation for Licensing-out and regulatory submission?
We are here for you!
PK/PD analysis through modeling & simulation provides
strategic advices to accelerate your drug development process.
Early Phase Clinical Trials
Phase 0 – IIA
We provide a full range of services on early phase clinical trials in healthy volunteers. Q-fitter’s top-notch investigator and clinical research coordinator (CRC) are delegated to provide operational management services. Along with the supportive services, advisory services from a clinical pharmacology perspective, including designing and revising a protocol, are offered. Our scientific writing includes but is not limited to protocols, Case Report Forms (CRF), Informed Consent Forms (ICF) and Clinical Study Reports (CSR).
- Early-phase trial designing
- Protocol development
- Trial-related document development (CRF, ICF, various forms, etc.)
- New therapeutics regulatory affairs (Cell therapy, Gene therapy, etc.)
- CRF fill-up + Quality Control (QC) /Quality Assurance (QA) activities
- Statistical analysis and CSR writing
Type of Clinical Trials
■ First-time-in-humans (FTIH)
- Micro-dosing studies (Phase 0)
- Single Ascending Dose (SAD)
■ Multiple Ascending Dose (MAD)
■ Bioavailability / Bioequivalence (BA/BE)
- Formulation comparison
- Combination formulations
■ Food effect studies (FE)
■ Drug-Drug Interaction studies (DDI)
■ Thorough QT studies (TQT)
▶ Both in healthy volunteer and patients
■ Endocrinology & Metabolism
■ Infectious Diseases
■ Natural Products