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Clinical Trials Services
- Time of issue:2020-12-16 15:03:31
Improve the quality of management and quality control standards can help enterprises to establish a quick way to market pharmaceutical products, in accordance with the technical requirements for clinical research CFDA this document on clinical research in the various stages of new drugs, and to develop the overall and stage drug discovery research strategy ʱ?? And to obtain high-quality clinical research data. I ~ IV covers new drug clinical trials (including bioequivalence, pharmacokinetic studies generations), Ⅱ ~ Ⅲ class medical equipment clinical validation.
1、Provide efficient and accurate Ⅰ / Ⅱa clinical trial early development programs
ⅠClinical trial requires rapid assessment of the potential impact of pharmaceutical ingredients for drug development strategy, we need sponsors for the study, providing a comprehensive solution for the rapid advance of treatment, while laying the foundation for future clinical trials.
Ⅱ/ⅢClinical trials & mdash; & mdash; early exploration potential drugs
Effective control of clinical research time, high-quality finish Ⅱ / Ⅲ clinical trials and clinical research in a timely manner to achieve the desired results.
ⅣClinical study period / Listed
After listing a variety of well-known pharmaceutical regulations and systems, can be tailor-made risk management plan, successfully reaching clinical research requirements, effective cost control clinical research market. Far Rui biological clinical research team, earlier than the company set up, has extensive clinical and practical experience of project management, including innovative early stage clinical research drugs and follow-up of II, III, IV clinical research, including Simcere has been successful, Columbine medicine, Yasuhiro medicine and many other pharmaceutical companies to complete all kinds of new drugs and medical devices in clinical research for several dozen projects, covering areas such as cancer (cytotoxic drugs, targeted small molecule drugs, macromolecular protein and antibody class drugs), anti-infective, cardiovascular, digestive, respiratory, blood, obstetrics and gynecology, endocrinology, traumatology, orthopedics.
We work with systems Hospital, Beijing Medical University (Peking University First Hospital, People's Hospital, Beijing Medical University Third Hospital), Chinese Academy of Medical Sciences hospital system (Cancer Hospital, Fu Wai Hospital), West China Hospital, Third Military Medical University in Southwest hospital, Sichuan Provincial People's Hospital, Jiangsu Provincial People's Hospital, Shanghai Jiaotong University system hospital (Ruijin hospital, Zhongshan hospital), Guangzhou, Zhongshan Medical University hospital system (Zhongshan Cancer Hospital, first Hospital of Sun Yat-sen), more than 30 domestic pharmaceutical clinical research institutions (especially national commitment to science and technology projects of major pharmaceutical research institutions) maintain close contact clinical cooperation.
2.1 Quality and Quality Assurance
By professional medical staff quality assurance organization, in accordance with pre-established and controlled operating procedures to ensure that in the course of clinical trials OMV businesses comply with GCP standards, the implementation of the customer or the company's SOP, to meet customer expectations and service research .
⊙Develop effective audit plan
⊙The quality of reporting of clinical trials management office to filers
⊙Ensuring appropriate quality standards and maintain
⊙Ensure timely corrective measures, in accordance with established plans to implement
⊙Responsible for receiving inspection department regulations
⊙Ensure a true and complete high ethical standards and testing standards
Clinical trials of the whole system to check the implementation of the evaluation tests, probability and data analysis whether the experimental plan, standard operating procedures and clinical trials of drug-related regulatory requirements match.
⊙To sponsor various branches Examiner
⊙Research centers and third-party inspection door
⊙On procedures for compliance, whether real experimental data, integrity questioned
3、Data management and statistical analysis
To provide economic and quality-assured clinical data management services. Biostatistics department Rui Chengdu far from the well-known biostatistician auspices, with experienced professionals in data management and statistical analysis, to ensure the timeliness and accuracy of test data processing operations in strict accordance with laws and regulations. Through partnerships with domestic and international electronic clinical trial system suppliers, we can also according to customer requirements, provide remote data entry and management and other services based on Internet ECT.
Professional medical writer, has in a number of therapeutic areas rich practical experience, writing achievements are in line with ICH guidelines and other registration requirements, to ensure quality within the stipulated time to complete the task.
⊙Clinical trial protocol, case report forms, informed consent of preparation
⊙Clinical trials summary report, a review of medical articles and references
⊙Clinical trial-related documents translation