Clinical Study Protocol

We are recognized as one of the leaders in designing EFSA compliant clinical study protocol design aiming to substantiate health claim or novel food authorizations.

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Service details

Following the evaluation of the strengths and weaknesses of the previously performed studies and EFSA opinions, we will design the relevant protocol which takes into consideration EFSA requested criteria for the evaluation of applications for authorization of health claims made on foods, including:

  • Specific procedures for human intervention studies (adequate control group, full randomization, treatment allocation concealed, power/ sample size calculation, etc.)
  • Appropriate dose for the recommended conditions of use (according to the labeling or project of labeling)
  • Relevance of inclusion/non-inclusion criteria for the study population in view of the target population for which the claim is intended
  • Biological and analytic validity of the surrogate markers of the claimed effect
  • Relevance of the main criteria of efficacy in view of the wording of the target claim
  • Adequacy of the intervention’s duration in view of the recommended conditions of use and the claimed effect
  • The scientific background relative to the study