Get the evidence you need to demonstrate efficacy
The overwhelming majority of natural health products enter the research process at Phase 2. Why? The goal of Phase 1 research is to evaluate whether or not a product is safe enough to use for larger studies. Because natural products typically consist of ingredients with a lengthy history of use in human health, preliminary safety data already exists. As a result, natural products begin the research process with a focus on efficacy.
Phase 2 clinical trials evaluate the effects of a product on its target population. They tell us whether or not products work at their intended purpose. These studies range from a few dozen to a few hundred participants and can include multiple treatment groups. They also monitor for safety and provide evidence for biological activity (i.e. proof of concept), optimal dosing (i.e. dose-finding studies), and related endpoints.
Our team creates a custom plan for your Phase 2 clinical trial to maximize the potential for demonstrating your product’s efficacy. Our researchers recognize the demands for timeline management, low cost, regulatory requirements, and minimized risk. We mitigate these concerns by integrating our expertise in the natural products field, providing you with productive returns on your investment.