The standards for design and performance of clinical trials:

We are the first and only to apply full pharmaceutical Good Clinical Practice (GCP) to all Natural Health Product (NHP) studies regardless of regulatory category. The benefit is that you know the quality of your study data will stand up to scrutiny by regulatory agencies.

A clinical trial is a highly complex and regulated process that has three phases and can last for months to years. These phases include the study startup, the actual conduct of the study in human subjects, and the closeout including the analysis of the data collected during the conduct. Each phase is critical and can make or break the results of the study if not performed properly. If the study is not set up properly, the data collection will be incorrect. If the data collection is incorrect, the analysis will not yield the answer to the underlying purpose of the study. There are over 200 steps in starting up the study, another 200+ in conducting the study, and at least 100 involved in the closeout. These 500 steps are highly interconnected and need to be looked at as a single entity rather than a series of unconnected tasks. It takes years of experience and expertise to understand the study product, study design, and regulatory requirements for a successful study.