All the members of SAFE CORE Clinical Team come from well-known pharmaceutical companies, both domestic and international, with an average of more than 10 years of experience in drug R&D and clinical operations. SAFE has established strategic cooperative relationships with more than 100 hospitals across the country, and owns and operates four self-built clinical trial facilities. A number of other facilities are operated on the basis of strategic alliance. Currently, SAFE is conducting 5 BE clinical trials Additionally 1 NCE clinical trial and 2 more clinical trials intended to be submitted to US FDA, all under GCP. Four more clinical trials are in the pipeline and 2 registrations have already been completed..
Clinical Core Competence
• Bioequivalence studies • Phase I-IV clinical trials • Clinical protocol design • Independent clinical trial audit • Pharmacovigilance • Data management and statistical analysis • EDC system • Medical translation • Registration Consulting service
• Human safety/tolerance test • Phase I-IV clinical trials • Pharmacokinetic • Drug-food interaction • Population pharmacokinetic • Pharmacokinetic/Pharmacodynamic Correlation •Bioavailability/Bioequivalence service
• CNAS certified Central laboratory • Excellent and stable R&D team with extensive clinical research experiences • One-stop quality service