China Med Device provides turnkey solutions for all clinical pathways in medical device/IVD/CDx/combination products.
Key clinical pathways are: Clinical evaluation report (CER), and clinical trial, overseas clinical data acceptance.
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 trials 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:
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
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).
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.
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.
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).
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.