Clinical Trials for Every Budget
Fixed prices. Predictable timelines. No surprises.
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.
One: Treatment Time
How long does it take for your product’s effects to be observed?
Hours? Days? Weeks?
Two: Sample Size
Our team offers 3 sample sizes for fixed-price studies. Small (n=60), medium (n=90), and large (n=130).
Three: Outcome Measures
Here’s where you tell us what your product can do. We customize the study to ensure it can find all of the benefits of your product.
1-2-3 Study Planning
Fixed Price Packages
Each package provides a complete randomized, blinded, controlled clinical trial consisting of:
- Customization of the Study Protocol, Methodology, and Data Analysis Plan
- Compilation of the IRB authorization documents
- Creation of informed consent documents
- Submission of the IRB documents to an accredited review board and all associated fees for expedited (low risk) trial authorization
- 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 (if applicable) to each participant
- Collection of 8-12 outcome measures at 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, advanced statistical analysis, and assessment
- Monthly updates on the research progress for projects lasting longer than 3 months
- Compilation of a 1-page visual presentation of the study’s findings for lay audiences
- 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 deliver exploratory trials for low-risk products or interventions, and are not suitable for outcomes which require an IND (Investigational New Drug) registration with the FDA.
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, or you need help choosing the best research options for your product, contact our team for a quote that meets your exact needs.