Medical Affairs
Noahpharm owns a group of high-quality clinical experts and a well-trained medical team, and enjoys a good reputation for acquiring the high-quality clinical trial data and meeting customers’ expectations on clinical development. Different from counterparts, we take into account products of different customers, design protocols using technologies such as bridging or exemption based on clinical quantitative pharmacology, and formulate for customers the practical and feasible clinical development strategy, which could greatly shorten the drug clinical development time and further cut clinical fee. Besides, we can independently design and conduct the clinical trial protocol for mass balance study.
There was a successful case that, based on our well-established design of phase I protocol and clinical quantitative pharmacological method, our customer could directly proceed to phase III study with exemption from phase II study granted by CDE.
• Medical writing
• Medical monitoring
• Clinical pharmacology analysis
• Pharmacovigilance