Who does Radicle Science work with?
Radicle Science works with supplement brands, contract manufacturers and ingredient suppliers. We have democratized the clinical study process, enabling any health and wellness brand – big or small – to undergo validation and prove their true effectiveness beyond placebo.
What can Radicle Science do for my nutraceutical product brand?
Radicle Science provides the first ever easy path for health and wellness products to prove their true effects beyond placebo. Radicle’s crowdsourced, virtual, direct-to-consumer (D2C) clinical studies deliver objective health outcome data across diverse conditions and populations – all at unprecedented affordability, speed, and scale. Since launching in 2021, Radicle conducted clinical studies on >20,000 Americans for clients ranging from startups to billion dollar publicly traded companies. Contact our team to learn how we can help your brand.
Why “Radicle” Science?
Radicle refers to the root of a plant, connecting to our mission to go back to the roots of mankind’s original medicines, heal with the roots of nature, and get to the root of the problem. Said out loud, it sounds like “Radical Science.” This serves as a constant reminder of our audacious business model and our radically disruptive approach, balanced by our commitment to scientific rigor and evidence.
How do Radicle Science template studies compare to Contract Research Organizations (CRO's)?
All Radicle Science study templates are condition focused on a primary outcome while also including secondary and exploratory outcome measures in an effort to evaluate broader effects of the intervention. All of our studies are designed by renowned researchers who are experts in their field, often in collaboration with major academic institutions. The study templates are always reviewed and approved by a central Institutional Review Board (IRB) in accordance with federal regulations set forth by the FDA.
Which conditions does Radicle Science currently study?
All Radicle Science study templates condition focused on a primary outcome while also including secondary and exploratory outcome measures in an effort to evaluate broader effects of the intervention. Our currently available study templates include sleep, stress/anxiety, pain, energy, appetite management, cognition and quality of life/overall health. New studies focused on digestive/gut health, immunity and women’s health will soon be available.
Do your studies include biomarker testing?
Radicle Science hasn’t implemented any biomarker testing at this time, as biomarkers aren’t appropriate for the currently available studies. Participant reported outcomes, or PROs, are the gold standard for the conditions we currently study. In the future, there may be studies where we incorporate biomarker testing.
How do I receive my study results?
Brand Report: Our Radicle Discovery Report provides a summary of the study outcomes. The report includes clinical study overview, statistical and clinical insights, usage patterns, and side effect profiles. Additionally, we deliver a clean annotated data set for any additional internal analysis.
BONUS: You’ll also receive a deep-dive consultation with representatives from our research and data science teams to answer questions about the report.
What are joint marketing opportunities with Radicle Science?
We are open to joint marketing events as well as media and press opportunities prior to and/or following the studies. Study information will never be shared without prior review and approval by the brand.
Can we publish our Radicle Science studies?
Radicle Science can work with your brand to create a manuscript for a potential peer-reviewed publication for an additional fee. Please keep in mind we can’t guarantee publication. Radicle Science is also happy to support our brand partners with press releases and other media coverage.
How do we track adherence and compliance of participants?
Radicle provides usage instructions on the study insert and via email. We ask about product usage in each survey, as well as side effects. We communicate with participants regularly to encourage and remind them to complete surveys.
We track how many surveys each participant completes, as well as make sure they understand how to take the products according to the manufacturers’ suggestions.
What kind of claims can I make?
Radicle conducts all of its studies based on well supported scientific principles. The standard for substantiating structure/function claims for dietary supplements under FDA and FTC law is that the claim is supported by data that qualifies as “competent and reliable scientific evidence.” See the FDA’s Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act available here. (“The FTC has typically applied a substantiation standard of “competent and reliable scientific evidence” to claims about the benefits and safety of dietary supplements and other health-related products. The FDA intends to apply a standard for the substantiation of dietary supplement claims that is consistent with the FTC approach.”).
While Radicle believes that its evidence gathered generally qualifies as competent and reliable scientific evidence, only the FDA, the FTC, and the courts can make the final determination that any evidence is strong enough to substantiate a specific claim. As a result, you would need to check with your legal counsel to ensure that your expressed and implied claims about your product are adequately substantiated under all aspects of the law.
Please refer to this document for more information.
Can I use evidence on one product to substantiate claims for another product?
If the products are different in some way such as potency, formulation, or form factor, then evidence to support one product’s claim may not be applicable to the other, since there isn’t a guarantee both products will have the same effect.
What are the Radicle Science offerings?
Radicle Science offers a series of studies that provide deep customer insight for targeted marketing and generate objective evidence to enable strong claims.
Please refer to Our Offerings page to view the full list of Radicle research studies.
What are the differences between Radicle Proof and Radicle Discovery?
Can I have different product forms in any of my study arms?
All products must be the same product form and look the same (it is a blinded study) i.e., you cannot have three capsules, two gummies, and one oral spray (unless you will have a matching placebo for each product form). Similarly, you cannot have one red gummy, two yellow ones, and a green one.
How do I create my dosing information?
The instructions for use for all your study arms (active arm(s) and placebo) must be the same.
What is the vision behind Radicle Science?
Radicle Science has a singular vision –we will challenge the status quo by democratizing the clinical study process and unleashing personalized health outcome data. Our vision is a future where affordable health and wellness products are trusted by patients, recommended by healthcare providers, reimbursed by insurance, and used as widely as pharmaceutical drugs.
Radicle Science is a B-corp. What does that mean?
A benefit corporation, or B-corp, is a for-profit corporation recognized by the majority of U.S. states that is driven by both mission and profit. Shareholders hold the company accountable to produce a financial profit as well as a specified public benefit. As a Delaware Public Benefit Corporation, our commitment to “increase public awareness of safe and affordable treatment options for the benefit of individuals who are in need of such treatments by studying and sharing objective health outcome data” is part of our corporate charter, as stated in our certificate of incorporation.
Can I join a Radicle Science study from home?
Your participation is 100% virtual. We ship the product directly to your home, and you share information about your health and your behaviors through our online surveys. All your information is kept strictly confidential.
How do I sign up to participate in a Radicle Science study?
To be the first to know about enrollment and sign up for future studies, please subscribe to our newsletter here. We’ll reach out when we begin recruitment. You’ll then be asked a few screening questions to see if you qualify. Thanks for your interest in helping us gather data on health and wellness products!
I just signed up for a Radicle study. When will I receive my product?
After enrolling in the study, we send you an email that lets you know that we’ll be in touch. It usually takes a few weeks for us to get everything ready to go, so don’t worry if you don’t hear from us right away.
We’ll send you an email asking you to complete the baseline survey. Within two weeks after the baseline survey is completed, we send you an email when your study product ships with a tracking number. To be clear, you have to complete the baseline survey to get your product.
How long do Radicle Studies last?
Radicle studies are short and most of them last about 4-6 weeks! We ask you to take your study product as directed during the study and answer the surveys that we send to you through email or text message. We’ll send you a final and feedback survey to take at the end. It’s so easy!
What do I get for participating in Radicle Science studies?
You will receive a Personalized Health Report which provides insights based on your study responses and tells you how you did, along with the product for the study at no cost to you.
Can I discuss the study with my healthcare provider?
Of course! You can always share information about the study with your primary doctor or healthcare provider. You can continue to see your doctor throughout the study for routine visits and tests.
How are Radicle Science studies different from other studies?
Our core focus is gathering clinical data to validate health and wellness products, the first of its kind! Our virtual, direct-to-consumer studies enable a smooth experience for participants, as well as enabling us to bring much needed equity and diversity into medical research. The unprecedented scale and reach of our studies finally enables inclusion of diverse ethnicities, genders, age groups, behavioral habits, and pre-existing health conditions to move us closer to personalized medicine for the population at large.