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CRO:
The Department of Clinical Affairs was established in 2005, with a major mission to conduct clinical trials for the two
Category 1.1 new chemical drug candidates. As a company managed by returnees, we have recruited a team with very high
caliber. Most of the members have medicine related background and graduated from top tier universities in China, such as
Shanghai Medical College of Fudan University, Peking Union Medical College, with M.D. or Master degrees. Everyone in the
Department has multi-year relevant working experience and is familiar with SFDA regulations and protocols of clinical
studies. CRAs have to receive training of GCP and SOP to insure the quality of our clinical trials.
After two years of effort, the Department of Clinical Studies have established a nationwide hospital network, including the
prestigious Peking Union Medical hospital, Cancer Hospital of Chinese Academy of Medical Science , The First Hospital
Affiliated to China Medical University, Beijing Chaoyang Hospital, Beijing Cancer Hospital, and Zhongshan Hospital Fudan
University. Our quality, attitude, and organization have won good reputation among clinical researchers and medical doctors.
We have established our own opinion leader database in the area of pulmonary disease and cancer.
Other than Shanghai Headquarter, we have established Beijing Office to strengthen our communication with hospitals in Beijing
area. This significantly improves our efficiency and reduces cost. We are currently offering CRO services for Phase I - IV
clinical trials and bio-equivalent trials, including:
Consulting: evaluation, planning, and budgeting
Selection and evaluation of clinical trial centers
Design of clinical trial protocol, CRF, inform -consent form, and investigator's brochure
Organize clinical trial meetings, including protocol discussion, coordination, trial initiation, mid-term evaluation, and conclusion meetings)
Monitoring, including site visit and tele-conference
Patient recruitment and management
Audit
Conclusion report
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