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statistical consulting services for clinical research which includes protocol design, sample size calculation, data
analysis that support statistical design. Considerations on non-inferiority studies, equivalence studies should be taken on deciding your statistical
strategy. Well written statistical section for clinical protocol is one statistical consulting service that Secic Statistical provides. Biostatistics
statistical aspects of protocol development, statistics is the basis for your protocol. A
Step-by-Step Approach to Non-Inferiority/Equivalency Trials Medical devices evolve incrementally. Non-inferiority or equivalency trials are often
used to establish that a new device is the same as or no worse in performance
than an existing device. This unusual strategy might be used to demonstrate that
a material substitution in an existing device is undetectable by the customer,
or it might be used to support a substantially equivalent argument in a 510k
.