CLINICAL TRIALS FOR NATURAL PRODUCTS
Your products work. It's time to make them clinically proven.
You need evidence that meets FDA and FTC standards; not pharmaceutical assumptions applied to supplements.
The Challenge: Why Most Supplement Studies Fail
Most supplement trials fail not because products don't work, but because they're designed wrong.
Pharmaceutical CROs apply drug trial methodology: disease biomarkers, patient populations, pharmaceutical endpoints. But your product doesn't treat disease; it enhances wellness in healthy people.
Budget nutraceutical CROs cut corners: minimal screening, poor compliance tracking, basic statistics that miss real effects.
The result? Expensive studies that can't substantiate claims.
Natural products require trials designed specifically for natural products, from endpoint selection to participant screening to statistical analysis.
Endpoints make or break your study.
Stress. Brain fog. Pain. Fatigue. PMS. These are the outcomes consumers care about—and the outcomes your products target.
But how do you measure them?
Many researchers default to proxy biomarkers: heart rate for stress, blood pressure for anxiety, EEG for brain function. These lab measures have their place; they provide objective data and regulatory credibility.
But here's the problem: Proxies don't directly measure the outcome consumers experience.
Your customer wants to know: "Will this reduce my stress?" Not "Will this change my heart rate by 10%?" Heart rate fluctuates throughout the day based on dozens of factors unrelated to stress perception. Blood pressure can be elevated without anxiety, and normal despite severe stress.
Relying solely on proxy biomarkers creates two risks:
First, you miss the real effect. Your product reduces perceived stress and improves daily function, but cortisol didn't budge. The biomarker says "no effect" even though users feel dramatically better.
Second, you can't substantiate the claim consumers care about. The FDA and FTC require evidence that matches the claim. If you claim "reduces stress," proxy measures alone may not be sufficient.
Our Approach: Comprehensive Measurement
We use validated psychometric tools developed specifically for natural product research in non-diseased populations, combined with relevant biomarkers when appropriate.
The Nutraceuticals Research Institute measurement suite includes proprietary scales for:
- Stress and anxiety (perceived stress, daily function impact)
- Cognitive function (brain fog, focus, mental clarity, memory)
- Pain (intensity, interference with activities, quality of life)
- Sleep quality (onset, duration, restfulness, daytime impact)
- Energy and fatigue (physical and mental energy, vitality)
- Women's health outcomes (PMS, menopause symptoms, maternal wellness)
These psychometric tools capture:
✓ Direct measurement of the target outcome (not proxies)
✓ Real-world effects that matter to consumers
✓ Sensitivity to detect changes in healthy populations
✓ Validity and reliability for claim substantiation
✓ FDA/FTC compliance for natural product claims
When biomarkers add value, we include them: hormone panels for women's health, immune markers for elderberry, wearable technology for sleep aids, inflammatory markers for pain studies. But we never rely on biomarkers alone when measuring wellness outcomes that are best reported through participant input. The result? Studies that capture both what consumers feel AND what regulators require: defensible evidence that your product delivers the benefits people actually experience.
The measurement tool determines whether your study succeeds. We ensure it's comprehensive, fit for purpose, and built for natural products.
Your study needs people who match your consumer base.
To substantiate claims, trial participants must match your customer base. If your product helps college students cramming for exams, the study needs college students during finals, not retirees.
The FDA requires evidence in populations that will actually use the product. Different people respond differently to botanicals.
But here's the challenge: Your customers are disease-free but not perfectly healthy. They're seeking improved wellness. Finding and enrolling these specific populations requires public health expertise— not just clinical research experience.
Our team includes public health professionals who identify exactly who will benefit most from your product, ensuring enrollment criteria match both regulatory requirements and real-world consumer profiles.
Most Trials Fail at Enrollment and Retention
Industry-wide, over 80% of clinical trials fail to meet enrollment goals. Many firms respond by lowering standards, enrolling anyone available, resulting in poor compliance and high dropout rates.
Poor compliance destroys study quality. If participants aren't using the product correctly, the data can't validate effects. High dropout rates introduce bias and increase false negative risk.
Our Solution: We've built a community of engaged volunteers who want to participate in natural product research. This community is demographically consistent with natural product consumers. By focusing on participant experience, we achieve:
- 95%+ retention rate
- Near-perfect protocol compliance
- Recruitment costs a fraction of industry norms
We don't accept noncompliance as inevitable. We design trials participants can actually follow.
We're Natural Health Professionals AND Research Scientists
Most research firms are pharmaceutical companies treating supplements as a side business. They force complex botanical products into pharmaceutical study designs.
Your aromatherapy blend isn't a drug. Your adaptogen doesn't work like a pharmaceutical. Cramming natural products into pharmaceutical protocols misses what makes them work.
Our Difference: Every researcher on our team is a trained natural health professional: aromatherapists, herbalists, health coaches, dietitians.
We understand:
- Phytochemistry and botanical interactions
- How essential oil blends deliver effects
- Proper dosing for botanicals (not pharmaceutical dosing)
- Common misuse patterns (and how to prevent them)
- Culinary strategies for unpalatable supplements
This expertise prevents study failures that pharmaceutical researchers can't anticipate, such as inadequate dosing, poor application methods, compliance issues with texture or flavor.
Research Leadership: Trials are led by a Harvard-trained researcher and research associates with graduate training in epidemiology, public health, and clinical methodology. Natural health expertise plus rigorous scientific standards.
We Design Trials Based on Your Product's Strengths
Too many trials fail due to:
- Underpowered studies (wrong sample size)
- Poor endpoint selection (wrong measurements)
- Weak intervention protocols (participants can't follow them)
- Inadequate statistical analysis (can't isolate true effects)
Our Approach:
Power Analysis: Industry standard accepts 20% false negative risk (1 in 5 trials fail due to size alone). We cut that risk in half with properly powered studies.
Endpoint Selection: Hand-selected to match your product's actual effects, not generic outcomes.
Intervention Design: User-friendly protocols participants can actually follow—proper doses, realistic schedules, practical application.
Statistical Analysis: Comprehensive plans that eliminate noise and isolate true effects. No p-hacking, no dubious techniques, no shortcuts.
The result? Trials designed for success, not just data collection.
High Quality Trials That Actually Substantiate Claims
A "successful" trial that doesn't meet FDA/FTC quality criteria cannot substantiate claims.
The FDA evaluates trials on:
- Study population (matches product users)
- Study design and conduct (rigorous methodology)
- Data collection and statistical analysis (appropriate methods)
- Outcome measures (fit for purpose)
Poor quality trials are common: wrong populations, proxy endpoints, p-hacking, inadequate power, sloppy statistics. These don't fool regulatory agencies, and your company pays the price.
Our Commitment to Quality:
The overwhelming majority of our studies are published in peer-reviewed journals or presented at scientific conferences.
This provides:
- Free press for your product
- Additional evidence your trial is high quality
- Confidence in claim substantiation
We don't just deliver data. We deliver defensible evidence.
Expertise in Populations Others Avoid
We specialize in populations that require additional expertise:
- Pediatric trials (children, adolescents)
- Women's health (pregnancy, menopause, maternal health)
- Wellness outcomes (stress, sleep, cognitive function, energy)
- Botanical interventions (essential oils, adaptogens, herbs)
These populations and outcomes require nutraceutical-specific methodology, not pharmaceutical protocols adapted to supplements.
Clinical trials don't have to cost millions
That pharmaceutical price tag? It's for high-risk drugs in high-risk populations with dangerous side effects and invasive monitoring.
Your product has centuries of safe use. It's self-prescribed at health food stores, not physician-prescribed through regulated pharmacies. It enhances wellness, not treats disease.
Your trial shouldn't be designed like a pharmaceutical trial.
Our Approach: We design custom strategies around natural product-specific FDA/FTC guidelines for dietary supplements and cosmetics, not pharmaceutical regulations.
We prioritize:
- Ethics compliance and data protection
- Quality control appropriate for health-enhancing products
- Cutting-edge designs (hybrid trials, non-invasive measures)
- Elimination of pharmaceutical-industry overhead
The result? Substantially lower costs without compromising quality. Often improved quality through appropriate methodology.
Transparent Pricing: Every trial is custom-designed based on your product's needs and your budget. With extensive expertise in both natural products and clinical research, we create solutions that work financially while meeting scientific standards.