Clinical Trial Data Management

According to the "Regulations on the Supervision and Administration of Medical Devices" (Order No. 739), Class I medical devices are subject to product filing management, and clinical trials are not required, but clinical evaluation data need to be submitted; when Class II and III medical devices are registered , clinical trials should be conducted (except for medical devices in the list of medical devices exempt from clinical trials); medical devices exempt from clinical trials must still provide clinical evaluation data when applying for registration.

Service Process:

Our Services and Time Distribution:

• CRF design 15 working days after obtaining the final protocol
• Build database(Epidata) 30 working days after the protocol is finalized
• Regular CRF(paper version) 30 working days after receiving the CRF delivery plan
• Annotate CRF 7 working days
• Compilation of the database filling guide 2 working days
• Preparation of data management plan 5 working days
• Data entry 20 working days after the last batch of CRF was collected
• Medical coding 2 working days
• DVP data verification plan 10 working days
• Data query 15 working days after data entry
• Data review report 10 working days
• Data management report 5 working days
• Database lock 3 working days after data cleaning is completed