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4.希米科医药技术发展(北京)有限公司 The CMIC Group consists of fifteen companies, including CMIC Co., Ltd. and consolidated affiliates. The Group's businesses mainly involve support for the pharmaceutical industry. Instead of making drugs, we offer comprehensive services related to drug, all the processes of a pharmaceuticals company from research and development to manufacture and sale. Leveraging our experience and expertise as a pioneer CRO, our business has expanded to create added value in such fields as drugs, medical devices, specific functional foods, and so on. Moreover, we are tackling the service which is useful to "the medical treatment for a patient" also in the field of medical treatment and healthcare, strengthening customer service as "PVC (Pharmaceutical Value Creator)" which contributes for value maximization of a pharmaceuticals company.
) A* M/ ^8 U& {* e/ N- _The main businesses of the CMIC Group are as follows:% w8 q* Y1 d; s2 m7 C6 U
' `, ?2 x( Y6 L3 P' fMonitoring: T+ _/ s V3 m2 i
The client in a clinical trial (e.g. a pharmaceuticals company) appoints monitors to track the progress of a trial and, whenever necessary, ensures that the trial is conducted, recorded, and reported in accordance with GCP (Good Clinical Practice), GPSP(Good Postmarketing Study Practice), as well as with the protocols and standard operating procedures (SOP). Monitors also collect this data, make and keep a record of related actions, and prepare for approval inspection.' t5 C% x3 Q9 G; ]
Data management
& f1 I* y2 Q: l" N6 W; FMonitors or medical representatives (MR) use computers to save the case report forms (CRF) of clinical trials obtained from clinical investigators and to conduct statistical analyses.Statistical analyses involve the use of a database made through data management on drug efficacy and safety in compliance with the notice from the section head of the Ministry of Health and Welfare entitled "Statistical Principles for Clinical Trials" (ICH E9) issued in 1998.
+ J( v z$ h6 D) D4 ^CRC business
" H: W) Q. V% b) c+ aOur business as a clinical research coordinator involves screening subjects, lending support in obtaining informed consent from subjects, registering subjects, caring for subjects, and so on, all under the guidance of doctors. This enables clinical trials to be conducted smoothly to produce quality outcomes.
0 N7 }( w. I$ C5 U5 qPharmaceutical affairs consulting
# E2 _* y( s# m% E/ FOur pharmaceutical affairs consulting services include support in submitting drug development application documents as well as development of, applications for and marketing of drugs, medical devices and specific health foods.In addition, we can act as a domestic administrator that supports overseas pharmaceutical manufacturers that do not have a sales base in Japan, assisting them in overall drug development, including making contacts with the Ministry of Health, Labor and Welfare.
* e, ]* Y( v* b @Pre-clinical work, d) _9 ?5 T- V3 ~
We undertake preclinical work to precede clinical trials on behalf of pharmaceutical companies. Preclinical work includes stability tests, microorganism tests and drug concentration tests.Stability tests with medical drugs include long-term storage tests, acceleration tests, severe tests, light stability tests and relative comparison tests.. [: N2 o2 f( E5 z" {8 o( t0 G
Website:http://www.cmic.co.jp/e/index.shtml
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