Welcome to Trust-medicine

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.


Clinical monitoring
Our medical department cooperates by many highly qualified and experienced team and project managers.

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

to the ethics committee report, the test drug destruction, filing, etc.

Conclusion stage

recycling CRF table, filing, etc.

Going stage

visit plan, clinical quality control, etc.

Start stage

clinical research plan, prepare the manual, select the clinical unit, to apply for ethics committee
Data management
Our data management department by the most authoritative biostatistician and data management experts.

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

Clinical trial design
  • • Design research plan statistics

  • • Sample size calculation

  • • Randomization process

Data management
  • • 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

Statistical analysis
Our biological statistics department by the most authoritative biostatistician and data management experts.

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


Clinical trial information integration
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.

Registration and regulations


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

Medical translation
Translation purpose

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.

accurate and rapid


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.

professional


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.

GMP certification and verification consulting and other
Company by the good faith as the basis, take the quality as the guarantee, to success as the goal

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!

Including national GMP certification, GAP certification, GSP certification, certification of GPP, etc,
  • Train

    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.

  • Org

    2. Prepare: / guidance establishment URS, SIA  CCA files as well as, all kinds of validation protocol/report, etc.

  • Imp

    3. Implementation: the implementation/guidance for equipment validation, test method validation, cleaning validation, computer validation, process validation, etc.

Our service including
The medical market and policy research
The medical market and policy research

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

京ICP备11043991号 版权所有:2015-2030北京信立达医药科技有限公司 | http://www.trustcro.com/

Technical support:北京至善至美文化传播有限公司