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.HGRACApproval
7.OBR Review and Approval
6.Project Establishmentin Sites
5.Protocol Discussion Meeting
9.Clinical TrialAgreement 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.StatisticalAnalysis
24.Study Close-out
23.Clinical StudyReport
22.Site SummaryReport
21.Summary Meeting
25.Site Close-out
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).
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.
