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Clinical Trial Services

China Med Device integrated team with clinical, technical and regulatory expertise can assess the optimum balance of your status of CER, overseas clinical data and clinical trial services and reduce sample size when clinical trial is the only option.

China Med Device’s bilingual, bicultural team can provide the complete CRO service to help you conduct China GCP compliant clinical trial and manage the complete clinical trial process to obtain the final clinical trial report. Our CRO services includes but not limited to:

  • Clinical trial assessment
  • Clinical trial protocol design
  • Sample size determination
  • Hospital & ethical committee review & approval
  • Clinical trial auditing
  • Monitoring and ensuring data quality with CRC and CRA, data management, analysis and reporting
  • Managing AE/SAE
  • Statistical analysis

Clinical Trial Phases:

1.
Preclinical Documents Preparation

3.
Animal Study
(if applicable)

8.
HGRAC
Approval

7.
OBR Review and Approval

6.
Project Establishment
in Sites

5.
Protocol Discussion Meeting

9.
Clinical Trial
Agreement Signing

10.
Provincial/Local NMPA Filing

12.
Patient Recruitment/ Enrollment

16.
Data Collection

15.
Interim Analysis
(if applicable)

14.
Follow-up

13.
Treatment /
Observation

17.
Data
Management

18.
Data Q&A

19.
Database Lock

20.
Statistical
Analysis

24.
Study
Close-out

23.
Clinical Study
Report

22.
Site Summary
Report

21.
Summary Meeting

25.
Site
Close-out

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2. Study Document Preparation

Clinical trial protocol design is the first step of conducting a clinical trial in China. The protocol design needs to consider the requirements of China Good Clinical Practices (GCP).

china-med-device_clinical-trial-services_step-2-icon_study-document-preparation2

4. Site Evaluation and Selection

China Med Device will work with you to determine a list of qualified sites. CMD will evaluate each site’s qualification based on certain criteria including location, patient recruitment rate, costs, investigator background, etc.

china-med-device_clinical-trial-services_step-11-icon_site-initiation

11. Site Initiation

During the study implementation stage, it needs to be clarified that site management is conducted by two functions: Clinical research associate (CRA) and Clinical trial coordinator (CRC). CRA will be sent by CMD to conduct site visit monitoring. CRC represents the site and needs to be involved in the whole process of clinical trials to assist investigators. In China, most of sites do not have full-time CRCs to manage clinical trials at the hospital. Therefore, contract CRCs need be hired to ensure the appropriate site daily management. CMD will work with the hospitals and clients to hire the appropriate CRCs to assist in the trials.