Therapeutic Equivalence (non-Inferiority) & Superiority Studies
for Locally Applied/Acting & Fixed-dose Combination Products

• Study design, protocol, e-CRF & ICF development
• Study conduct
• Clinical site selection, recruitment, initiation, monitoring, close-out
• Study site management
• Data management
• Statistical analysis
• Clinical Study Report
• Investigator & study personnel training
• Medical, study & protocol specific, ICH-GCP