Clinical trials means any clinical trials in the human body (patients or healthy volunteers), the systemic research of the drug, to confirm or to reveal the role of the experimental drug, adverse reactions and/or testing of drug absorption, distribution, metabolism and excretion, the purpose is to determine the curative effect and security of the test drug. The person participate in clinical trials are called volunteers on abroad, but ‘subject’ in China. The Volunteers are healthy people, also are the patient, this basically see what kind of testing is to attend. We usually contact with most of the test, by the patient, it aims to investigate new drugs to have curative effect and any side effects. The doctor let patients taking the drug, it must obtain the consent of the patient, after a certain period of treatment, look at the efficacy and side effects of the medicine. The most important thing is that clinical trials must meet our ethical requirements, we must respect his (her) personality and conform to the participants' interests, in this premise, test can do. And during the test, participants can don't need any reason, not to continue the test, he (or she) choice, including doctors, all people have no right to interfere. In short, the careful design, operations, clinical trials, is to improve human health, search for new drugs and methods of treatment, the fastest the most safe way.
Company has a perfect quality management and quality control system, to ensure the project process in line with the requirements of GCP, and can obtain high quality clinical research data, can fully meet customers in the pharmaceutical products of all kinds of requirements in terms of clinical trials.
Clinical monitoring center service content
End stage
Conclusion stage
Going stage
Start stage
experienced professional staff to data management and statistical analysis, and have long-term cooperative relations to domestic well-known biometric experts. Statistics department as part of the team, to ensure timeliness and accuracy of testing data processing, in strict accordance with the laws and regulations, can meet the requirements of different customers.
Data center service content
• Design research plan statistics
• Sample size calculation
• Randomization process
• Data transfer
• Data management plan
• Database design, and testing
• Data logic verification program (EC) write and test
• Training and support of the EDC system use
• Data logical examination and medical examination
• Paper CRF double entry
• Query management
• Batch of import of the external data
• Medical terms coding
• Blind state audit, data and reports
• Case report form (CRF) and e - CRF design
• Database lock
Experienced professional staff data management and statistical analysis, and domestic well-known biometric experts have long-term cooperative relations. Statistics department as part of the letter rieter group, can ensure the timeliness and accuracy of the test data processing, operating in strict accordance with the laws and regulations, can meet the requirements of different customers.
Statistical analysis of content of the service
• Quality control of the statistical programming
• Database, sorting, conversion, derivative calculation
• Statistical programming
• Visualization data deｓｃｒｉｐｔion
• Interim analysis
• Statistical analysis report
• Drug safety assessment and analysis
• Statistical analysis plan
• CDISC standards data submission
Research and development to perfect the structured electronic medical records
In clinical medical information standardization, digital processing, on the basis of according to the application of clinical medical activity of traditional Chinese medicine (TCM) and TCM syndrome differentiation and treatment of clinical thinking mode to build a structured electronic medical records, to adapt to clinical medical information collection, medical record writing and adapt to the organic combination of scientific research and analysis of the data management and mining, be in harmony are an organic whole.Information collection and a simultaneous with the development of medical treatment activity, in line with the clinical medical work processes and habits.
Clinical and scientific data sharing
Use of clinical medical research information integration system can be convenient, shortcut, collecting clinical medical information, and timely, accurate and true to digitize clinical medical text information collection, directly into the required data, no need for clinical medical information processing can be directly for scientific research, has realized the clinical scientific research and information sharing. All the information comes from clinical practice and medical activities as to accumulate, rich information, data, objective truth, conform to the scientific research of traditional Chinese medicine ‘result of clinical’ features.
For clinical research of traditional Chinese medicine provides the advanced practical technical support
Using this system to store the massive clinical information data, can carry out all-round scientific research work. For the symptoms of the disease, syndrome elements, syndrome classification and study of syndrome distribution regularity, of study, research, research on the laws of the compatibility of the formulas and the formulas the ralationship, concentration-response relationship, aging, the screening and optimization of the treatment plan research, standard guidelines and standards, and the research of TCM scale data to provide information and technical support. Both the large volume of conducting clinical research database, make the full use of the clinical medical information, and provide statistical analysis for clinical trials, data mining, the scientific evaluation to provide technical support.
I company for the domestic and foreign customers with drugs, medical devices and health food,
such as different stages of project registration or entire journey service,
make the product market permission in the shortest possible time.
药品国内注册
• Provide registered agent identity
• Registration data review and guidance
• The feasibility evaluation of the domestic registration
• Quality standards review
• Registered all-the-way tracking
• Registration data sorting and submit
We have many years of experience in professional data translation translation department, has a number of professional translators, professional cover medical, biology, medicine, chemical industry, etc.
To ensure the accuracy of the translation and professionalism, the company also hired a number of translation consultant, he (she) are registered, clinical trials, drug research and development, senior experts in the field of medicine.
Native speakers and hired a corresponding professional advisers to the translation of translating from Chinese into foreign languages. For product registration information such as academic references data, provided by senior pharmaceutical professional translation, proofreading, and advisory services.
Company by the good faith as the basis, take the quality as the guarantee, to success as the goal, the pursuit of long-term development, and create a win-win situation, for partners to provide professional, standard, quality policies and regulations consulting related services.Welcome to inquire!
1. Training: provide validation of the special training, including how to prepare the URS, SIA CCA risk assessment, a variety of equipment, how to validate and test method validation and cleaning validation training, the training of computer validation and process validation, specific training project visible business plate is introduced.
2. Prepare: / guidance establishment URS, SIA CCA files as well as, all kinds of validation protocol/report, etc.
3. Implementation: the implementation/guidance for equipment validation, test method validation, cleaning validation, computer validation, process validation, etc.
We have extensive and in-depth research on the pharmaceutical industry,
relying on powerful strength and a high level of professional market research management consultant team,
focusing on the occasion of medical market at home and abroad, is committed to global customers to provide pharmaceutical market research in the field of professional solutions, integration of industry resources, service for the customer creation value.
Phone
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Technical support：北京至善至美文化传播有限公司
