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Clinical Trial Statistical Analysis

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:

  • Randomization plan, random table template(first draft)  3 working days after the plan is finalized
  • Statistical analysis plan (first draft)                                    7 working days after the protocol is finalized
  • SAS programming                                                                25 working days after the database is built
  • Statistical analysis report (first draft)                                10 working days