Services
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Medical Information
Medical Monitoring
Pharmacovigilance
Operation management of DSMB/CEC
● Design/writing/consulting of medicine Phase I-IV clinical research protocols
● Design/writing/consulting of research protocols for medical instrument beds
● Design/writing/consulting of real-world and international multi-center clinical research protocols
● Writing of summary report of clinical research
● Design/writing of informed consent form, research medical record and case report form.
● Writing of researcher's manual
● Prepare medical monitoring plans
● Review the eligibility of subjects
● Medical review of AE/SAE  
● Medical review of concomitant medication
● Medical review of deviation/violation of protocols in the research process
● Medical review of medical coding in the research process
● Medical review of EDC input data
● Query solving from the perspective of medical specialty
● Medical review of the documents in the research process
● Writing of the management plan of pharmacovigilance for SUSAR
● Confirmation of known adverse reactions of products
● Establishment and maintenance of security database
● Receiving, input, coding, duplicate checking, review and medical evaluation of SAE during clinical trials
● Medical review and report of SUSAR during clinical trials
● Quality control, communication, follow-up and problem solving of SAE/SUSAR report
● Writing of Development Safety Update Report (DSUR)
● Preparation of DSMB/CEC Committee
● Writing of articles of association of DSMB/CEC
● Safety events/clinical events, collection and analysis
● Review by members of Coordination Committee
● Summary and report of review results
Experience
? Clinical research on 150+ drugs
? Clinical research on 100+ medical devices
? Participate in CHANCE Research initiated by Professor Wang Yongjun from Beijing Tiantan Hospital during the whole course
? Be responsible for the first international multicenter clinical research initiated by the Chinese hospital