There’s a difference between saying what your product can do and proving it.
Clinical trial data is often the missing piece between a compelling claim and the audience you’re trying to reach. Through a well-designed clinical trial, you’ll be able to validate your label claims and gain a competitive advantage in a flooded marketplace.
At SNI, we understand the need to balance marketing with science and regulatory compliance. That’s why we approach the claims validation process from all angles. By engaging with your team early, we can advise you on the right clinical research pathway to achieve your goals.
Based on the claim you wish to support and the population of interest, we’ll advise you on the right study design and endpoints that will give you the best chance at success.
In many cases, we will recommend the appropriate claims or angles based on the clinical data.
A clinical trial with an optimised study design will be prepared to validate the intended claims. When designing claims validation studies, right dosage form, dosage amount, frequency and duration of product administration will be determined. In addition, right end points that represent the claims in the target population will be specifically chosen. Number of participants needed to provide the statistical power for the study will be estimated using statistical sample size calculations.