Early Ph​ase Clinical Trials​

Phase 0 – IIA

Services

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

Resources 

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

Therapeutic Areas

■  Cardiology

■  Endocrinology & Metabolism

■  Hematology

■  Infectious Diseases

■  Immunology

■  Neurology

■  Oncology

■  Rheumatology

■  Urology

■  Vaccines

■  Natural Products