Service Introduction

Jiushun Management provides service of Medical Devices Clinical Trials for you. The company has a professional clinical research team with a rich, skilled of experience providing a reliable software and hardware protection to ensure the high quality and efficiency of medical device clinical trials.

Excellent performance of the Jiushun fields in the industry great popularity.

Main factors of clinical trial success:

一、Optimal design of Clinical Trials Protocol

In order to provide the correct decision for the clinical planning, decision maker of the clinical plan should have a comprehensive understanding and the authority of the decision of the clinical intend use of medical devices. Experts need a combination of theoretical education and a wealth of industry experience.

二、Successful implementation of clinical trials

All details of a clinical research plan, which is strictly in accordance with the requirements of clinical trials, must be scientific, comprehensive and reliable. The research could obtain the true data and conclusions of the device. All work of clinical trials must be carried out strictly in the relevant regulations as the most fundamental basis.

三、Extension of enterprise resources

Successful clinical trials play vital roles for the approval of the device. Jiushun and the State Food and drug administration have good relations of cooperation can be extended to clinical trials in rich resources of regulations and technical, so as to ensure the quality of clinical research and minimize exposure to review, making customers to maximize benefits.

一、Scope of clinical trial：

（一）MD II and MD III；

（二）IVD；

（三）Clinical trials and related services for other medical devices。

二、Content of clinical trial :

（一）Pre-clinical preparation and clinical trial plan preparation

（二）collection data of concerned product（product technical requirements、package insert、test report.

（三）ensure information of concerned product include the following ：

1．The purpose of clinical trials of medical devices

2．Content of clinical trial

3．Product function mechanism, working principle, structure, main characteristics

4．Intend use、contraindication、possible adverse event

（四）Prepare the preliminary overall design plan, including the following:

1. Clinical trials method，setup control group when necessary ，expected loss rate、determine the number of testing case

2. Scope of selecting subjects, reasons for the selection，evaluation method of clinical performance and statistical processing method.

3. Safety, effectiveness, feasibility analysis, Analysis of risks and benefits of clinical trials, expected adverse effects and the necessary measures to be taken

4. Data management, Confidentiality issues, responsibility allocation

三、Design of Clinical Trials Protocol：

1. Guidance for clinical trial design of medical devices;；

2. Formulating a clinical trials protocol

四、Communication with the hospital

1. To select a medical institution according to regulations and contact the clinical trial center

2. Communicate with the equipment section on the relevant documents (Type testing reports, instructions).

3. Contact the director of the Department, confirm the clinical trial plan, such as the number of cases, clinical standards and determine the clinical fee

4. Sign the clinical trials protocol and the contract which both parties have agreed to

五、The Ethics committee     

Preparation the following data for the hospital ethics committee and obtain approval required to declare:

（一）Clinical Trials Protocol, Research Manual, the main researchers resume

（二）Notice of Informed Consent, recruiting subjects procedures, the related content of compensation

（三）The case report form specimen；

（四）To provide the medical institution with the products to be tested for free, control with medical devices, related proof materials

六、Implementer of Clinical Trials

（一）Subject recruitment

（二）To train the personnel for clinical trials

（三）Clinical trial process tracking

（四）To record the clinical trials, to collect, manage and verify the case reports

七、Data management：

（一）CRF designing；

（二）Medical encoding；

（三）Database establishment and verification；

（四）Data input and double contrast examination program of data query,

（五）Clinical data review, question table,solve the question

（六）Blind verification，Data lock，SAE Check。

八、Biological statistics：

（一）Participate in clinical trials protocol design, put forward the statistical requirements；

（二）Sample size estimation；

（三）Statistical analysis of two programming and cross validation by SAS,

（四）Interim statistical analysis,

（五）Data analysis, the development of independent statistical analysis report。

九、Clinical Trials Report     

（一）Clinical statistical analysis report

（二）The general clinical trial report

十、Authenticity verification

（一）To check the clinical materials, including Notice of Informed Consent, the subjects' signature, the consistency of the case report, the statistical analysis method and the accuracy of the clinical report.