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