Randomized Controlled Trials
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.
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.
Clinical Trials for Every Phase of Development:
Collectively, feasibility studies reduce the risk of error in large-scale research by ensuring your clinical trials will not be conducted on the wrong dose, the wrong population, or for the wrong duration.
These provide you with a realistic overview of the potential for success in large-scale clinical research, allowing modifications to dosing, exposure, or even formulation to take place before expensive studies are conducted.
Feasibility studies identify:
- The minimum dose or serving size required to produce measurable effects
- The target population for your product (i.e. the population which sees the greatest results)
- The most prominent effects that can be documented from your product
- The shortest amount of time required to see measurable health benefits
- The frequency of exposure, dosing, or administration of your product required to produce benefits
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.
Phase Two Trials:
- Efficacy Confirmation: substantiating product efficacy to unlock new structure/function claims, OTC drug claims, or the progression to Phase 3 clinical trials for products under an IND
- Formulation Superiority: allowing for comparison of differing formulations to identify the optimal formula
- Dose-ranging and Dose-response Testing: providing data regarding potential benefit of increased or more frequent dosing models, identifying the most effective exposure to your product
- Effect Size: our team evaluates total effect size above the placebo response, allowing you to identify the meaningful effect, not merely statistical significance
These studies also support prevention claims and structure/function claims for non-drug products. They build upon the work of phase 2 studies, and allow us to identify how your product compares to the standard of care, how it interacts with other treatments, and what rare reactions might exist.
Phase 3 Clinical Trials Identify:
- How your product’s effects may vary in diverse populations (i.e. by sex, race, geographic region, health status, etc).
- What rare side effects and adverse effects are possible.
- Key usage details required for your product’s comprehensive drug label.
This critical stage of your project requires a unique blend of expertise to ensure results can be replicated in a larger scale with a more diverse population. Our team can work with you to develop studies build around your product’s features to meet FDA standards.
Our team also manages expanded participant recruitment, timelines, complex databases, and FDA updates.
If your research is stalled, you’re not alone! In recent years, close to 80% of clinical trials fail to meet their enrollment deadlines and nearly 50% of research sites enroll either one patient or none at all. What does this mean for you? Lost revenue for every single day these delays keep you from your new claims.
In the nutraceutical/integrative health industry, clinical trials are a relatively new concept. While the total number of clinical trials registered has skyrocketed, the number of published trials remains stagnant.
Many clinical trials, particularly in the integrative health industry, remain unfinished due to delays, mismanagement, or unforeseen complications.
If you have a clinical trial that is stalled, or you suspect may be at risk, rescuing your research should happen sooner rather than later.
Fixed Price Trials
What if a clinical trial for your product could give you peace of mind, with a fixed price and a predictable timeline? Now it can. Our research team offers the ability to choose the right study duration and sample size for your product, with a clear, upfront cost and guaranteed timeline. No surprises.
Starting at only $20,000, fixed price study packages deliver a complete randomized, blinded, placebo controlled clinical trial in a matter of months. Your product’s effects can be in the scientific literature within a year, allowing you to enter new markets with substantiated health claims.
Fixed price studies are ideal for aromatherapy products, dietary supplements, medicinal drinks, OTC monograph products, substantiating FTC claims, structure and function claims, herbal products, cosmetics, and many other markets. Clinical research on your products is now as easy as 1 – 2 – 3.