Study Endpoints
NRI works with a wide range of study endpoints, with each study being exclusively designed to feature your product's greatest strengths. Each trial will consist of a unique combination of endpoints, which may include psychometrics, (both proprietary and licensed), blood draws, and other laboratory tests such as saliva and stool.
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Proprietary Psychometrics
Patient Reported Outcome Measures (PROMs) are critical for today's clinical trials. Factors such as stress, mood, pain, or even quality of life, require participant input for valid and accurate assessment. Most PROMs were not developed or validated to capture changes to health status for nutraceutical studies, so NRI created and validated proprietary instruments that objectively capture effects other tools often miss.
NRI has exclusive ownership for validated, multi-dimensional scales that measure:
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Stress
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Sleep
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Mood
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PMS
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Menopause
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Energy/Fatigue
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On Site Laboratory Tests
Nutrient absorption studies, screening procedures, and other routine needs are all filled through routine laboratory draws (whole blood or serum). This provides a lengthy selection of biomarkers including hormones, vitamin and mineral levels, liver and kidney function, blood sugar levels, inflammatory markers, various metabolites, and so much more. Depending on the protocol, these draws can be included for both localized and decentralized studies.
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In-Home Laboratory Tests
Some outcomes, such as salivary cortisol or stool samples, should be collected in the home to avoid interference with the target lab value. For example, site visits can increase cortisol levels, which leads to less reliable results. Our participants are trained to collect saliva, stool, urine, or even dried blood spots in-home, ensuring compliance and protecting your study's validity.
Examples of in-home lab tests include:
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Cortisol Awakening Response
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Comprehensive Stool Analysis
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Dried Blood Spot testing for hormones and other unique biomarkers
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Nasal Swabs for influenza or COVID-19 incidence
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Licensed Psychometrics
In addition to our proprietary measures, NRI utilizes existing gold standard licensed psychometric tools. These can be used to add additional endpoints, such as pain, state or trait anxiety, or other psychological outcomes. They can also be added to a study for comparison purposes to collect a single outcome, measured through multiple instruments.