How DTC Brands Can Launch Product Research Studies Without Physical Sites

Why Health Claims Need Broader Research

For fast-growing wellness brands, the right health claim can change everything.

We’ve seen brands 3x their conversion rate by testing the right positioning – “supports deeper sleep,” “improves recovery,” “reduces bloat.” But which claim will resonate most with your customers and withstand regulatory scrutiny? You won’t know until you test.

That’s where decentralized research studies come in.

Instead of testing with a local population near a research clinic, remote studies let you explore real-world product use across different geographies, lifestyles, and demographics without opening multiple sites.

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Traditional, Site-Based vs. Modern, Virtual Studies

A few years ago, launching a claims study looked something like this:

Biomarker & Survey Data You Can Use to Support Health Claims Remotely

Many functional health claims like reduces stress, improves sleep, boosts focus, or supports recovery can be substantiated using:

• Self-reported outcomes (clinically validated assessments and instruments)
  
  
• Generated health data (HRV, sleep stages, resting heart rate, EEG)
  
  
• At-home test kits (nasal swab, saliva, dried blood spots, microbiome tests, vaginal swab, etc.)
  
  

These tools unlock access to rich, robust data without requiring a site-based setup.

Of course, for certain endpoints or regulatory pathways, in-person data may still be necessary. But the vast majority of consumer wellness claims can be explored, and often validated, remotely.

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How One Brand Explored Multiple Claims, Virtually

A DTC supplement brand offering a recovery-focused product wanted to explore how their formulation might support sleep quality, overnight recovery, and next-day well-being after taking the product.

What We Did

Together, we designed an 8-week observational study using Alethios’ decentralized platform. The study was approved by an independent IRB and followed real-world usage patterns, no in-person visits, no behavior assigned. Participants simply:

• Wore their existing wearable device (e.g., Fitbit, Apple Watch, Oura)
• Logged daily activities and supplement intake daily
• Completed short morning and weekly clinically validated and consumer perception surveys
• Received clear consent documentation and data access

What They Got

In under two months, the brand had:

• A de-risked, IRB-backed protocol
• Nation-wide recruitment with diverse participant demographics
• Real-world physiological and subjective data synced directly from participants
• Clear indicators of which potential claim areas showed the strongest signals

This gave them flexibility to pursue multiple types of claims – from consumer perception to wearable-based signals to exploratory biomarker insights, all from the same real-world study.

They walked away with:

• Directional signals for future clinical research
• Multiple data-driven narratives for product positioning
• Subpopulation insights to tailor messaging for specific customer groups

In other words: both marketing mileage now and a stronger scientific roadmap later.

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What About Regulatory Considerations?

Once you’ve gathered this level of robust, multi-source data from wearables, validated surveys, and at-home biomarkers, you’re in a strong position to craft claims that are precise, responsible, and grounded in evidence.

Often, a single decentralized study can support multiple claims, depending on how the data is segmented and analyzed. For example:

• A general recovery claim across your full cohort
• A focus or energy claim in a subpopulation (e.g. users aged 35–50)
• A sleep improvement claim tied specifically to wearable data
  
  

The power of virtual studies is not only in the data collection, but also in the flexibility of interpretation, so long as the claims remain scientifically and ethically sound.

You don’t always need FDA approval for structure/function claims, but you do need to ground your claims in appropriate context.

That means aligning your messaging with the actual study design, population, duration, endpoints, and data quality. Whether you’re building on existing literature or generating your own data, your regulatory risk depends less on the claim itself and more on how responsibly and transparently it’s tied to the evidence.

That’s why Alethios helps brands craft claims that reflect:

• The population studied
• The duration of the intervention
• The metrics and endpoints measured
• The level of statistical or observational significance

So your claims are not just marketable, they’re credible and regulatorily sound.

From Customer Research to Clinical Trials In One Platform

Whether you’re just starting to test positioning or ready to go full IRB-approved, Alethios gives you everything you need in one place:

• Digitized protocol builder
• Pre-built recruitment and consent workflows
• Support for wearables and lab kits
• Real-time monitoring dashboards
• IRB submission-ready in hours

No site visits. No middlemen. No six-figure overhead.

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Launch Your First Decentralized Research Study

You don’t need a brick-and-mortar site to start clinical research. You need a platform that meets your customers where they are and gets you the insights to grow.

Schedule your free study consultation

Alethios helps DTC brands move from guesswork to proof, faster.