Clinical Trial Service
Phase I-IV Clinical Studies
BE Studies
Real World Study and DDI
Relying on experienced professional medical team, standardized quality system, to ensuretheimplementation of clinical protocols
Clinical pharmacological study service (Phase I/PK/BE)
It mainly undertakes phase I, DDI, PK, BE and other clinical trial projects, the service scope covers the whole country. The services includes preparation and submission of ethical material, application of HGRAC, monitoring of clinical trial process and source documents and writing of monitoring report, assisting investigator in writing SAE report, preparation and submission of application material, writing of BE technical material and summary report as well as project whole process management. We have completed more than 70 clinical trial projects such as phase I, PK, BE and DDI, and many of them have passed the inspection of the NMPA and obtained the approval documents. The phase I coverage area of innovative drugs mainly includes liver cancer, breast cancer, leukemia, advanced solid tumor, etc. BE projects include highly variable drugs, endogenous drugs, slow and controlled release preparations, Inhalation preparation, injections, creams and oral dissolving films and other special preparations.
Phase II ~ IV clinical study services
It mainly undertakes phase II~IV clinical trial projects, the service scope covers the whole country. The services include the organization of relevant meetings, preparation and submission of ethical material,application of HGRAC,monitoring of clinical trial process and source documents and writing of monitoring report, assisting investigator in writing SAE report, preparation and submission of application material as well as project whole process management. We have participated in more than 20 phase II~IV clinical studies. The tumor indications include Non-small-cell carcinoma, Non-Hodgkin lymphoma, kidney cancer, thyroid cancer, liver cancer, solid tumor, breast cancer, etc., while other indications include insomnia, primary dysmenorrhea, eczema, urinary tract infection, pulmonary fibrosis, hepatitis, thrombosis, hypertension, senile cataract, myopia, etc.
Clinical trials coverage areas
