Medical writing

(1) preparation of basic documents for clinical trials

Research plan

Case report form

Informed consent

(2) initiation of clinical trials

The choice of researchers and research centers

Organization of the conference of researchers

Ethical declaration

Sign contracts with research centers

(3) management and quality control of clinical trials

Data management plan (DMP)

Data verification plan (DVP)

(4) summary and report of clinical trials

Statistical analysis plan (SAP)

Statistical analysis report (SAR)

Clinical summary report (CSR)

Medical supervision

Carry out feasibility investigation of the scheme and confirm the research strategy.

According to the test plan, the scope of work stipulated in the contract, the requirements of SOP and GCP, the research center screening, ethics submission, organization of the research conference, research center initiation, routine monitoring and Research Center closure visit, etc.

Clinical monitoring of different indications for phase I-IV clinical research

Monitoring of non intervention observational clinical research

Clinical monitoring of medical devices and in vitro diagnostic reagent tests