Clinical trials designed for natural products, not pharmaceutical assumptions
Most supplement studies fail not because products don't work, but because they are designed wrong. NRI builds trials from first principles: PI-led from protocol to publication. Your compound, your claims, your data.
Methodology that holds up in peer review and in the market
Survey studies and elementary descriptive stats get you a headline. Validated psychometrics and biomarker data get you a publication, and a headline that actually holds up. Two failure modes exist in nutraceutical research: pharmaceutical CROs applying drug assumptions to botanicals, and budget CROs cutting corners on measurement and compliance. NRI does neither.
NRI has developed and validated psychometric scales specifically for natural product research in non-diseased populations: the NRI Stress Response Inventory, NRI Energy Scale, NRI Menopause Symptom Scale, NRI Sleep Scale, and NRI Cognition Scale. These instruments capture what consumers actually experience at the effect sizes that matter for nutraceuticals.
Conditions we study
Every trial is custom-designed around your specific compound and desired claims. Click any condition to see the NRI proprietary instrument, endpoint domains, claimable outcomes, and relevant publications.
From first conversation to published paper
Every NRI trial is Dr. Cavanaugh-led from start to finish. No handoffs to junior staff. The researcher who designs your trial is the researcher who runs it, analyzes it, and puts her name on the publication.
Your compound, your claims, your consumer. Power analysis, endpoint selection, psychometric instrument selection or development, randomization, blinding strategy, intervention design.
Independent IRB review, informed consent, clinical trial registration. All handled. NRI works with accredited IRB partners with fully independent oversight.
Participant recruitment from our established community of engaged volunteers. Active compliance monitoring throughout. 95%+ retention, near-perfect protocol compliance.
Statistical analysis in Stata using advanced biostatistical techniques. Manuscript preparation and peer-reviewed journal submission. Work that earns its place in the literature.
GCP-compliant research from protocol to publication
Every NRI trial is designed and executed in accordance with International Council for Harmonisation Good Clinical Practice guidelines. That is not a marketing claim. It is the framework that governs how we document decisions, handle deviations, manage adverse events, and maintain data integrity across every study we run.
GCP compliance
All NRI trials follow ICH E6(R2) Good Clinical Practice guidelines. Protocol adherence, investigator responsibilities, source documentation, and audit trail requirements are built into our standard operating procedures, not added after the fact.
IRB oversight
Every study undergoes independent IRB review before enrollment begins. NRI works with accredited IRB partners with fully independent oversight. Continuing review, protocol amendments, and unanticipated problem reporting are handled as a matter of course.
Clinical trial registration
All applicable NRI trials are registered on ClinicalTrials.gov prior to enrollment. Registration is a publication requirement for most peer-reviewed journals and a signal of methodological transparency to reviewers and regulators alike.
Adverse event reporting
Adverse event collection, grading, and reporting follow established clinical research standards. Serious adverse events are reported to the IRB and sponsor within required timeframes. Every participant has a direct contact for reporting concerns throughout the study.
Protocol deviation management
Deviations are documented, categorized, and reported according to their potential impact on data integrity and participant safety. Minor deviations are logged. Major deviations trigger corrective action and IRB notification. Nothing disappears into a spreadsheet.
Data integrity and 21 CFR Part 11
Electronic records and signatures used in NRI studies comply with 21 CFR Part 11 requirements where applicable. Source data is captured at the point of collection, audit trails are maintained, and data locks are documented. Your regulatory-ready data package reflects this from day one.
Sponsors receive regular progress updates, access to enrollment and retention data, and advance notice of any protocol deviations or adverse events. You are not waiting for a final report to find out how the study is going. That is how it should work.
Full-service trial management
Every engagement is custom-scoped. These are the core components of a full-service NRI trial.
Study design and endpoints
Power analysis, endpoint selection, psychometric instrument selection or development, randomization, blinding strategy, and intervention design. Each study is built around your compound and your claims, not a template.
Enrollment and data collection
Participant recruitment, screening, enrollment, compliance monitoring, data collection, adverse event reporting, and oversight throughout. Our participant community is demographically consistent with natural product consumers.
Statistics and publication
Statistical analysis in Stata, manuscript preparation, peer-reviewed journal submission, regulatory-ready data package, and claim substantiation documentation. We do not just deliver data. We deliver defensible evidence.
Expertise in populations others avoid
Most research firms are pharmaceutical companies treating supplements as a side business. They lack the natural health expertise to design trials that reflect how botanicals actually work in real people. Every researcher on the NRI team is also a trained natural health professional: aromatherapists, herbalists, psychologists, dietitians, and public health scientists.
We understand phytochemistry and botanical interactions, how essential oil blends deliver effects, proper dosing for botanicals rather than pharmaceutical dosing, common compliance issues with texture and flavor, and how to enroll populations that match your actual consumer.
Children and adolescents ages 2 through 17. Age-appropriate protocols, fully validated outcomes, and the safety monitoring expertise these populations require.
Pregnancy, menopause, maternal wellness, and cycle-related outcomes. Populations requiring specialist methodology and instruments built for their specific experience.
Stress, sleep, cognitive function, energy, and mood in healthy non-diseased populations. The population most supplement brands serve and most pharmaceutical CROs cannot measure.
Essential oils, adaptogens, herbs, and whole-plant extracts. Trials designed for how botanicals actually behave, not how isolated compounds are expected to behave.
Custom-designed trials at natural product pricing
That 7-figure pharmaceutical RCT price tag is for high-risk drugs in high-risk patient populations with dangerous side effects and invasive monitoring. Your product enhances wellness. It should not be priced like a pharmaceutical trial because it does not pose the risks or require the environment of a pharmaceutical trial.
NRI designs custom strategies around FDA and FTC guidelines for dietary supplements and cosmetics, instead of borrowing pharmaceutical norms. The result is substantially lower costs with improved quality thanks to appropriate methodology.
Every trial is custom-scoped based on your compound, your claims, and your budget. Contact us to discuss scope and pricing for your specific study.
Ready to design your trial?
Every trial starts with a conversation. Tell us about your compound and your claims.