Clinical Trials (phase II - IV)

Therapeutic Equivalence (non-Inferiority) Studies

for Locally Applied/Acting generic products (Ophthalmic, Dermatological, Intra-Vaginal, Inhalers)

Superiority Studies

for Fixed-dose Combination Products

Investigator Sponsored Studies

Observational Studies

• 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