Once your drug is approved by the FDA, you are responsible for post-market monitoring. Your post-market analysis plan includes phase 4 studies which are carried out in the general population among volunteers who supply information for analysis. These data confirm that your product remains effective and most importantly, remains safe in a general population.
Make your research foolproof
The vast majority of integrative health products enter the research process at phase 2 clinical trials. Early phase 1 studies, which demonstrate safety, are rarely required for dietary supplements and botanical products. The purpose of phase 1 studies is to demonstrate evidence of safety in human use. This is a necessary step for pharmaceutical drug development, but most natural products benefit from extensive human exposure through traditional use.
Phase 2 trials evaluate efficacy; this critical step constitutes the vast majority of research in the integrative health industry as it is sufficient to substantiate structure and function claims and can also lead to FDA authorization to conduct phase 3 studies. After completion of sufficient phase 3 studies, a new drug application (NDA) can be submitted for drug authorization.
Clinical Trials for Every Phase of Development:
Phase 2 Clinical Trials
Phase 3 Clinical Trials
Phase 4 Clinical Trials
Fixed Price Studies
Identify Meaningful Effects
The purpose of phase 2 clinical trials is to produce evidence of efficacy for your product. These include small-to-medium sized samples, typically in 2-3 arms. At least one arm is a placebo arm and at least one arm is a treatment arm. Our team may design your study to include multiple control arms or multiple treatment arms, depending on your ultimate research goals. Feasibility studies or preliminary data analyses may be recommended to determine the optimal sample size to reduce the risk of false negative results. Studies for this phase typically include 20-80 participants per arm, depending on the population, the product, and the outcome of interest.
Our team focuses on clinically relevant effects from your product during this process. Many contract research organizations focus exclusively on p-values (statistical significance). While statistical significance is exciting, it fails to provide evidence that your product is capable of producing a meaningful effect. Our team emphasizes effect size throughout the process (from clinical trial development through data analysis) to confirm that your product has a measurable effect on the population within your priority market.
This confirms that your product is capable of delivering on structure/function claims or to progress to phase 3 studies under an IND. It also provides clarity on the effects of your product across varying demographics, providing data that prove invaluable to labeling and marketing efforts.