Did you know you may be able to run Phase 1 and Phase 3 studies in China in parallel, particularly for urgent medical needs?
Hear Lisa Lu, PSI CRO’s Country Manager in China, discuss how to determine if your study may qualify and how PSI’s local experts can help.
Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.
Hello, my name is Lisa Lu. I’m the country manager for PSI in China and I’m located in Shanghai. Let me share with you some relevant aspects for running clinical trials in China.
Did you know that for new drugs coming to China, it is needed to conduct a PK study in a Chinese population locally? One can apply for an IND for Phase 1 and Phase 3 studies at the same time.
Based on NMPA’s feedback, you can potentially run Phase 1 and Phase 3 studies in parallel. Urgent medical needs like hematology studies, and lethal diseases without any drugs available at the moment, have a higher chance in running Phase 1 and 3 studies at the same time.
Usually, a PK study needs 20 to 30 healthy volunteer subjects or patients, depending on the different indication and medicine.