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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:

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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