Overview
Scientific adviser
Clinical Research Institute is composed of four platforms including clinical pharmacological department, preclinical study department, clinical operating department and clinical science department, and a total of 36 employees, including 6 doctors and 12 masters.

Clinical pharmacological department
Mainly in charge of PK and PK/PD data analysis, ADME, quantitative dose-effect relationship study, dosage and administration route/method study in clinical trials, drug interactions, special crowdsand group pharmacokinetic study. Phase I and BE test design, operation and data analysis as well as interpretation.

Preclinical study department
A comprehensive department which isresponsible for small molecule original new drug study, including target point selection, pioneer compound screening, leading compound findings and optimization and candidate compounds druggability evaluation (preclinical pharmacodynamics, pharmacokinetics and toxicity) and preclinical development for all projects (including macromolecular biological medicine), as well astest designs, implementations, summariesand registration documentsforthese researches. The department also co-operatewith State Transnational Medical Key Lab for establishment ofefficacy evaluation platforms of tumor, neurosciences and immunity drugs and relevant R&D tasks.

Clinical operating department
The responsibilities of clinical operating department are:
1. clinical project implementation, management and quality control in accordance with SFDA regulation.
2. carry out clinical trials;performscheme development and organization, clinical center management and clinical process management for clinical projects along with clinical science department.
3. Complete clinical test summariesand reviews of each phase of clinical trials;assistthe registration department with NDAs.

Clinical science department
The responsibilities of clinical science department are:
1. Prepare clinical development plans and feasibility plans and make sure the R&Dof drugs meets clinical trial demands and the company's development strategy;
2. Make sure clinical test items including clinical test schemes, medical audit programs and test summary report,conform to scientificity, ethics principles and clinical regulations both domestic and international, guaranteeing smooth running of the clinical trials;
3. Data management and statistic analysis of clinical projects;
4. Clinical test result releasing and publication
5. Organize and support internal and external academic exchanges activities;
6. Provide clinical medicine science support for otherdepartments to ensure projects’ conformity with the scientific principle.

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