You know your products are effective.
We help you prove it.
Take your clinical trial from idea to publication faster, using fewer resources, with our highly personalized technical, research, and advisory services.
The Value of Clinical Trials
As a small dietary supplement company or supplier in a competitive market, you know how hard it is to differentiate the unique value of your products.
Ingredient efficacy and compliance information are commoditized. Generic brands are everywhere. Big online retailers are even staking their claim as low-cost providers of natural and organic products.
If you want to avoid the “race to the bottom” and instead make your nutritional products stand out from the crowd, you need to clearly demonstrate how they’re better.
You need clinical trial results.
The year-over-year growth in supplement clinical trials is 69% globally and 48% in the United States. As of July 2018, 896 open supplement studies were registered on ClinicalTrials.gov.
With consumers demanding both social and empirical proof before buying, few companies succeed without substantiating their marketing claims.
It’s no longer a question of “whether” you need to do a clinical trial, but “when.” And if the idea of conducting a clinical trial overwhelms you, book a free consultation to explore how we can help you succeed.
Not quite ready to chat? Follow these links to learn more, then contact us if you have questions!
How We Help
Your goals provide the foundation for our work. Having a clear picture of what you want to achieve creates a solid framework for the entire process.
We ask a number of questions to help you define your objectives, including:
- What claims would you like to make for your product?
- What are the best tools and tests to measure what you want to claim?
- How do we ensure that the data you obtain support structure/function claims to remain compliant with the FDA?
We use your answers to help us determine the trial size, scope, timeline, and cost.
Documenting your goals and trial details gets everyone on the same page. We help you design an efficient and rigorous trial, then we put the details in writing.
Some of what your RFP covers includes:
- Sample size and exclusion criteria
- Data for collection
This information helps Contract Research Organizations (CROs) provide realistic quotes – ones that are less likely to change down the road.
As with any big project, it’s a good idea to get multiple bids. But it can be hard to manage the details and make the right choice.
When you work with us, we:
- Act as your liaison with several CROs
- Answer questions they may have about your proposed trial
- Evaluate their proposals
If you receive multiple proposals, we summarize them and recommend the one we believe will be the best fit for your project.
Once you’ve chosen a CRO, it’s time to start your trial. If you’re like most small dietary supplement companies, you already have a lot of priorities on your plate. We remove the stress of “yet another job” by serving as your clinical trial project manager.
Over the course of your trial, we will:
- Make sure the CRO stays on time and on budget
- Conduct audits
- Review trial procedures
And, by overseeing your trial rather than running it, we maintain complete independence from the results.
This is the fun part that creates new opportunities for you and your company! We get to show how your product works, with solid science to back your claims.
Because this phase is fairly technical, most companies prefer to enlist research experts like us to:
- Review all the raw trial data
- Assess the data for quality
- Evaluate statistical significance
You receive both a detailed report and a summary of important findings to help you plan your next steps.
If you want to fully leverage your results for public relations and marketing, you’ll want to consider formally publishing your work in a peer-reviewed journal.
Not sure how to do this? No worries! We can do it for you.
Even if you choose not to formally publish, we’ll summarize your trial results in a way that is meaningful for you and your customers.
Your clinical trial is an important investment in both your company’s future and the health of the people you serve. You want to make sure you do it right, with someone who understands the implications and can guide you on multiple fronts.
Our 15+ years of corporate accomplishments, coupled with our entrepreneurial experience, will provide you with broad and deep knowledge in strategy, budgeting, project management, engineering, regulations, and marketing.
We get the big picture. You get what you need from your trial.
You already believe that superior nutrition improves people’s lives. You also understand the importance of validating what you know using scientific methods. You want advice and support from someone who values both.
Our advanced degrees in nutrition, integrative health, chemical engineering, and biochemistry give you access to thousands of hours of experience, knowledge, and training in nutrition, research, and product development. We’re also passionate about improving human health, naturally.
We trust nutrition, and verify with science. You gain credibility.
You’ve got enough on your calendar with the day-to-day challenges of managing your growing company. The last thing you need is added responsibility for supervising an intensive clinical trial process.
We specialize in facilitating clinical trials. You can be confident that when we manage your trial, you’ll get a clear and focused strategy, a detailed execution plan, and implementation oversight to ensure you get what you need.
We sweat the small stuff. You don’t have to.
Your success to date is no accident. You’re smart about where you invest your time and resources, and you want to be smart about how you conduct your clinical trial.
We always start small to keep your initial investment low. We focus on pilot and small clinical trials, and design them to learn as much as possible, as quickly as possible, with a limited sample size and minimal budget. As fellow entrepreneurs, we understand the importance of optimizing our investments.
We respect your time and resources. You get more of both.
You know your products are only as good as the quality of their ingredients. By the same token, you want to use quality research methods to ensure credible results for your clinical trial.
We excel at designing experiments, collecting data, and evaluating results using an unbiased, scientifically-accepted process to demonstrate product efficacy. Our top priority is to ensure trial validity so you can effectively use your results to differentiate your products in the market.
We do research right. You get verifiable results.
You’re in this business because you want to make a difference in people’s health and vitality. People matter. And you prefer to work with others who make people a priority.
We do, too. We limit our client portfolio so we can provide you with highly personalized service that is tailored to your unique needs.
We pride ourselves on developing deep and lasting client relationships that create long-term value.
We get to know you better. You get to know who you’re working with.
We offer a broad range of services, both packaged and a la carte, to help you with any or all of the six key phases of your clinical trial:
- CLARIFY GOALS. We refer to this phase, together with the next one, as the “Blueprint Phase.” We ask you a number of questions to help you define your objectives. We also complete a detailed evaluation of historical studies and methods for products that use the same or similar materials. We then recommend an appropriate trial size, scope, timeline, and financial investment that will have sufficient rigor and power to support your product’s efficacy while adhering to regulatory requirements.
- DEVELOP RFP. Here we document your goals and trial design to ensure everyone is on the same page. Your RFP will include such information as randomization, sample size and exclusion criteria, and data for collection. These details will help doctors, research clinics, and Contract Research Organizations (CROs) understand your objectives and provide realistic quotes.
- CHOOSE CRO. You’ll likely want multiple bids for your trial. But you probably don’t want the headache of reviewing multiple proposals and choosing one – especially if you don’t know much about CROs. We do that work for you, including acting as your liaison with CROs during the bid process, evaluating their proposals, and recommending the one we believe will be the best fit.
- OVERSEE TRIAL. We can manage your trial so you can stay focused on running your business. Over the course of your trial, we’ll act as a technical and planning liaison with the trial site and personnel. We’ll keep your trial on time and on budget, conduct audits, and review procedures. And, by overseeing your trial rather than running it, we maintain complete independence from the results.
- ANALYZE RESULTS. This is technical work that most companies prefer to outsource to research experts like us. Whether you’re conducting a trial that we helped you plan, managing a trial on your own, or even just trying to sort through other data that’s important to your business, we can help! We geek out on reviewing, compiling, analyzing, and interpreting data. Tell us what you’re looking for and we’ll get your answer using the appropriate statistics.
- PUBLISH PAPERS. Showing your work in a peer-reviewed journal offers significant public relations and marketing benefits. If you want to take full advantage of this option, but you don’t have the skill or capacity to pursue it, we’ll do it for you. We offer technical writing services for lay, clinical, and academic audiences. No matter whom you want to reach, we can share your result in a way that is meaningful to the reader.
- Phases 1-2 (Clarify Goals + Develop RFP, aka Blueprint Phase) take 4-6 weeks. You don’t want to rush this phase, as taking more time upfront minimizes obstacles later. We use this time to get crystal clear on goals, budget, expectations, and trial details.
- Phases 3-4 (Choose CRO + Oversee Trial) typically take 7-18 months. Your duration will depend on your chosen trial length (3, 6, or 12 months), how long your RFP stays open, the backlog of your chosen CRO, and Institutional Review Board (IRB) approval. We recommend adding 4-6 months to your chosen trial length.
- Phase 5 (Analyze Results) is completed in 4-6 weeks when you work with us.
- Phase 6 (Publish Papers) takes 5-9 months to complete the full process. It takes 4–6 weeks to draft the manuscript in the journal’s specific format. Once submitted, peer review can take anywhere from 3–6 months. Once accepted, your manuscript is usually published within 1–2 months, although this is dependent on the journal.
It depends on the package or a la carte services you choose. The more you have us manage, the less time you and your staff will need to spend on the details of the trial.
To better understand your options and potential time commitment, book a 45-minute, complimentary consultation with us!
Each trial is unique and highly dependent on 1) trial duration, and 2) how big a sample we need show significance in your desired variables.
We focus on pilot and small clinical trials to keep costs as low as possible, typically between $100 and $300K. Total cost will be more certain once we’ve completed the Blueprint Phase.
Want to learn more? Let’s talk. Your initial consultation is free.