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Service

Clinical Research Service

Service scope

◊ Pharmacokinetic study of single and multiple drug administration in human body；
◊ Human tolerance to single and multiple administration;
◊ Pharmacokinetic study;
◊ Study on material balance and biotransformation of human body;
◊ Drug interaction research;
◊ Drug interaction research;
◊ human bioequivalence research；
◊ Comparative study of pharmacokinetics.

Service scope

◊ Innovation medicine Ⅱ clinical research (medicine, biological products, traditional Chinese medicine and natural medicine);
◊ Innovation medicine Ⅲ clinical research (medicine, biological products, traditional Chinese medicine and natural medicine);
◊ Confirmatory clinical research (generic drugs, biosimilar drugs, medical devices);
◊ Clinical study of cell preparations (stem cells, CAR-T);
◊ Clinical research on special medical food.

advantage

◊ Chemical Medicine Research has nearly 20 years of research experience which can provide one-stop work in clinical pharmacology research, including clinical operation, analysis of large or small molecular biological samples, data management and statistics, etc.
◊ We participated in the establishment of bioequivalence test committee of Zhongguancun Jiutai drug clinical trial technology innovation alliance (formerly China GCP alliance) in 2017, which ensured the hospital and expert resources of phase I clinical research and BE.
◊ Chemical Medicine Research has participated in the construction of phase I clinical trial wards in 5 hospitals, and established strategic cooperation on phase I clinical trial with more than 10 authoritative hospitals in China.
◊ We have a biological sample analysis center, and the testing and analysis projects have been verified by the Food and Drug Inspection Center of the National Medical Products Administration. We have strong analytical and development capabilities, and has developed and established more than 100 large and small molecule detection and analysis methods.
◊ Chemical Medicine Research has an in vitro and in vivo data bridging analysis team consisting of pharmaceutical experts, non-clinical research experts and clinical experts to provide decision-making for research risks and solutions for collaborative projects, reduce risks and improve progress.
◊ Relying on the accumulated research experience and expert resources, adopting the concept of one-stop service to reduce the connection and risk between different research parts, thus improving the speed and quality of project research.

advantage

◊ The core clinical research team of Chemical Medicine Research is all from famous pharmaceutical enterprises at home and abroad, with an average of more than 10 years of clinical research and operation experience.
◊ We are committed to helping hospital obtain GCP certificate and participate in clinical research work. In 2013, we participated in the establishment and establishment of Zhongguancun Jiutai Clinical Trial Technology Innovation Alliance (formerly China GCP Alliance), which is the earliest company to enter this field and obtain the most GCP certificates in China. In this process, we have established cooperative relations with over 100 hospitals and accumulated rich hospital and expert resources.
◊ We have participated in hundreds of drug and medical device clinical trial projects, and the service has generated more than 10 trial data, involving tumor, cardiovascular, endocrine, digestive, mental and other treatment fields.
◊ The project management system which is in line with the actual research situation is established, the allocation of project management resources is strengthened, the flattening of project management is emphasized, and the responsibility of project management is assigned to specific department heads, so as to make the project get the most refined management and quality control.
◊ The project research process adopts electronic management and monitoring, so as to achieve the closed-loop of planning, implementation, quality control and feedback, to ensure the timely implementation of the plan, the implementation of quality control, quality control feedback, feedback a new plan, so as to ensure the quality of the project as planned.
◊ Attach importance to personnel training and management, emphasize the matching degree between project personnel and project, and control the impact of personnel turnover rate on the project from the source and through various measures.

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