Clinical trial characteristics of ophthalmology:
Due to the characteristics of ophthalmology such as the fine structure and important function of the eye, the professionality of ophthalmic examination, the special drug form, and the special use method, there are higher requirements for clinical trial of ophthalmology, from the protocol design to the clinical trial operation.
Establish good cooperation with many domestic ophthalmology clinical sites, have experience in monitoring and management of clinical trials of medical devices and drugs in various ophthalmic diseases areas.
Independent ophthalmic project management team: Ophthalmology is a key development area of the company and an independent team of ophthalmic project managers has been built for the management and execution of ophthalmic clinical trial projects.
Our clinical trial experience includes, but is not limited to, the following ophthalmic indications:
Cataract, glaucoma, ocular surface tissue and corneal defects
Our hospital resources coverage:
Beijing, Shanghai, Guangdong, Zhejiang, Tianjin, Hebei, Shandong, Hubei, Shaanxi, Yunnan, Jiangsu, Shanxi, Hunan, Heilongjiang, Chongqing, Liaoning, etc.
In July 2014, a collapsible intraocular lens for which the clinical trials was undertaken by our company was approved by CFDA. This product is the first self-developed aspherical collapsible IOL in China, which broke the technical monopoly of soft crystal of other countries in the research and development of high-quality new materials and optical design. Our company provided the whole process services for the clinical trial (protocol design, project management, clinical monitoring, data management & statistical analysis, final report writing).
In November 2017, GCP ClinPlus Co.，Ltd. held the first “Medical Device Clinical Trial Salon. Ophthalmology Area” in Beijing, supported by the China Association for Medical Devices Industry, Beijing Tongren Hospital affiliated to Capital Medical University, Peking University Third Hospital, the People's Liberation Army Navy General Hospital, Body Organ Biomedical Corporation and other units.
In April 2018, GCP ClinPlus Co.，Ltd. held the second "Ophthalmology Clinical Laboratory Clinical Trial Forum" in Shanghai, supported by the China Association for Medical Devices Industry, Beijing Tongren Hospital affiliated to Capital Medical University, Shanghai General Hospital, the People's Liberation Army Shenyang Military Region General Hospital and other institutions and experts.