Clinical Trials for Your Products

Fixed prices. Predictable timelines. No surprises.

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.

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.

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