Clinical Trial Substantiation for Every Budget

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.

Step 1: Choose your treatment time.

How long does it take for your product’s effects to be observed? Hours? Days? Weeks? Choose between 3 customizable options: 1-2 hours, 1-5 days, or 1-3 weeks. This determines how long our team will monitor for effects.

Step 2: Choose your sample size.

Our team offers 3 sample sizes for fixed-price studies. Small (n=60), medium (n=90), and large (n=130). If your product’s effects are extremely large, smaller sample sizes are appropriate. For moderate sized effects, larger samples are ideal.

Step 3: Select your outcomes.

Here’s where you tell us what your product can do. Fixed price trials measure 8-12 total outcomes, typically in 2-3 main categories. This protects your investment and allows our team to deliver multiple findings in a single study.

Some natural ingredients produce effects within minutes or hours. These studies tend to be quick and inexpensive because informed consent, baseline data collection, intervention administration, post-test data collection, and subject debriefing all take place in the same day at a single location. Other products, however, require days, weeks, or even months for the effects to be seen. For these studies, our team must follow the participant over time, monitoring their progress, collecting data at multiple stages, and maintaining the participant so they don’t drop out of the study. This process takes longer and results in increased costs.

Our fixed price studies offer you three options for duration. The first is for immediate effects. These studies are for products which can produce results within 1-2 hours. The second is for products which require up to 5 days to produce results. The final option is for products which require up to 3 weeks to produce results. For products which require monitoring over periods of time of 1 month or more, contact our team for customized protocol development and an accompanying quote.

The next step is to select the appropriate size for your study. Our team offers fixed price studies in 3 different sizes, depending on your product’s needs. In general, the larger the effect of your product, the fewer participants required in your study. Products with more moderate effects require larger samples for statistically significant results. Choosing the right sample size protects against false negatives. If you are not sure how many participants are ideal, our team can assist.

Small studies of 60 participants are ideal for products which have a large effect on the body. Because participant cost is the largest expense of a study, these are the most inexpensive studies to conduct. For products which have a moderate to large effect, medium studies of 90 participants are ideal. And for products which have a moderate effect on the body, 130 participants are required. All three study options collect evidence on effects that are considered large enough to be noticeable. If your product’s effects are small, contact our team for a customized protocol and quote.

The final step is to select your main outcome categories. Our team can measure a wide range of outcomes common to the natural products industry. Each outcome category includes up to 15 distinct outcome measurements, allowing our team to not only measure your product’s effects on this general outcome, but also specifics on the ways in which your product affects the body. This provides a wealth of information for new marketing avenues, target audiences, and health claim substantiation.

Outcomes our team measures include: stress, acute pain, chronic pain, state anxiety, trait anxiety, specific anxieties (i.e. social, medical office, autism spectrum-associated, etc), range of motion, emotional state, confidence, pre/post menstrual symptoms, quality of life, respiratory health, cold & flu symptoms, libido, cognitive health, attention span, academic performance, memory, assertiveness, self-efficacy, trauma, PTSD, body weight, stamina, endurance, productivity, coping ability, oral health, happiness, depression, eating disorders, intimacy, irritability, life satisfaction, creativity, mood disorders, eczema, warts, athlete’s foot, skin irritation, burns, cradle cap, digestive complaints, nausea/vomiting, coughing, sore throat, seasonal allergies, insomnia, constipation, migraines, and more.

Final Cost n = 60 n = 90 n = 130
Immediate Effects $20,000 $30,000 $40,000
Up to 5 Days $35,000 $50,000 $65,000
Up to 3 Weeks $45,000 $60,000 $75,000

Each package provides a complete randomized, blinded, placebo controlled clinical trial consisting of:

  • Customization of the Study Protocol, Methodology, and Data Analysis Plan
  • Compilation of the application for expedited IRB authorization
  • Creation of informed consent documents
  • Submission of the IRB application to the accredited review board and obtaining authorization from the board to conduct the study plus all associated fees
  • Registration of the trial at a registry approved by the World Health Organization
  • Recruitment of a random sample of adult participants
  • Adaptive randomization of the participants into two groups
  • Screening human participants for eligibility
  • Obtaining informed consent from each participant
  • Administering the intervention or placebo to each participant
  • Collection of 8-12 outcome measures both baseline and post-intervention
  • Participant debriefing post-intervention
  • Stipends for human participants
  • Subject monitoring for adverse outcomes (i.e. headaches, allergies)
  • Reporting of adverse outcomes to required oversight agencies, where applicable
  • Archival, storage, and maintenance of all data for the period required by law
  • Management of any random audits from human participant research oversight agencies
  • Data cleaning, statistical analysis, and evaluation
  • Monthly updates on the research progress for projects lasting longer than 3 months
  • Compilation of a visual presentation of the study’s findings
  • Compilation of a full research report in APA format
  • Compilation of a manuscript for journal submission in appropriate format, such as CONSORT or PRISMA
  • Filing of completion reports with IRB to close the study, and all associated fees
  • Filing of completion records with Clinical Trials registry
  • Submission of findings to academic journal for peer-review, including all revisions and updates

Please Note: Exploratory research packages can be used to substantiate structure/function claims (internal use products only), aromatherapy claims, cosmetic claims, OTC drug monograph-related claims, and FTC-governed claims. These packages are not suitable for outcomes which require an IND and these packages are not substitutes for phase 2 or 3 clinical trials. Studies which require an IND, full board IRB review, protocol changes or extensions, more than 2 subject demographic qualifiers, power analysis for customized sample sizes, samples large enough to measure small effects or side effects, more than 2 research groups, superiority comparisons, or dose comparisons require custom protocol development. If exploratory packages are not the right fit, contact our team for a quote that meets your exact needs.

Project Extras

For studies on children or pregnant women, participants are considered “vulnerable populations” and requires a surcharge of $10k for large effect sizes or $20k for medium effect sizes for oversight.

Packages include outcome measures collected by our research team. Measures which require copyright licenses or medical personnel may require a surcharge of up to $250 per participant.

Study findings are presented to your company in a user-friendly 8-10 page APA formatted document. A 60-minute video-based presentation for internal use is available for $1,400.

Package studies include data collection at baseline and the end of the study. Collection of additional data at midpoint or other intervals can be added for an additional charge.

See what our research team can do for you

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