Therapeutic Equivalence (non-Inferiority) Studies for Locally Applied/Acting generic products (Ophthalmic, Dermatological, Intra-Vaginal, Inhalers, Anesthetics & NSAIDs, Otic, Nasal)
- 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