microconstants > Success Cases > TQT Clinical Trial Capability and Case Study

TQT Clinical Trial Capability and Case Study

2018-11-30 13:53:17
TQT Trial for NDA at CFDA and FDA at the same time
      - New Drug for anti bacterial infection
      - Trial Conducted by Shanghai Huashan Hospital
      - 1st TQT Trial in Domestic Followed by ICH E14’s requirements
      - Protocol+ CSR in both Chinese and English , meet NMPA and FDA’s requirements
      - Initialed at Apr., 2017, several runs of training
      - 52 Subjects, 4 Phases, 205/208 ECG Continuous Collecting
      - All the materials for NDA in Bilingual were submitted in the 2nd Quarter of Yr2018

previous:Oncology Clinical Trial Capability and Case study
next:PK Case Study