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SAFE Service
Clinical Research
Clinical Research
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
Business Scope
• Human safety/tolerance test
• Phase I-IV clinical trials
• Pharmacokinetic
• Drug-food interaction
• Population pharmacokinetic
• Pharmacokinetic/Pharmacodynamic Correlation
•Bioavailability/Bioequivalence service
Core Advantages
• CNAS certified Central laboratory
• Excellent and stable R&D team with extensive clinical research experiences
• One-stop quality service