Back to customer servicesHealth-consumer products and wellbeing providers

Is the new formula worth another study? Define the one thing it must show first.

You have prototypes or internal trial-use feedback. Investors, distributors or purchasers want measurable evidence, but the team has not decided whether to measure acceptability, adherence or a health outcome.

How does this scope address your concerns?

Recruiting participants before choosing the right outcome wastes effort. Satisfaction or repurchase intent is not a health effect.

When this scope fits

Teams with formula, quality records and trial-use data that need to define population, comparison and outcomes before a study.
Teams assessing what a small feasibility study can answer before moving to an efficacy study.

When the scope needs adjusting

Using a few positive reviews to claim disease prevention or treatment falls outside this scope.
Recruitment, clinical delivery, testing, ethics submissions and full analysis require separately agreed qualified providers.

REAL SOURCES · ILLUSTRATIVE REQUEST · DOWNLOADABLE SAMPLE

Meal replacement v2: test feasibility before efficacy

Download sample packZIP

Measurement plan for a four-week pilot

01
Before start
Product/safety review, aims, ethics and data permissions
02
Week 0
Baseline, usual diet and satiety-measurement rules
03
Weeks 1–4
Use, adherence, adverse experiences, withdrawal and missing measures
04
Week 4
Prespecified outcomes and feasibility data; no effect numbers yet
05
Stage decision
Continue, modify or stop against predefined conditions

Four weeks and use are assumptions to assess, not nutrition recommendations. Sample size follows the primary outcome and feasibility aims; no favourable result is assumed.

Check	Finding / sample content	Use
Primary question	Willingness to buy does not replace the prespecified satiety outcome	Define commercial, experiential and health measures separately
Decision gate	First establish recruitment, delivery and data feasibility	Then decide efficacy-study design and budget

SOURCES USED IN THIS EXAMPLE

Prepared 5 Oct 2026 · Selected references, not an exhaustive systematic search

Scope & acceptance

Work covered by the quote

Define one finished-product version, one priority question and agreed records; choose feasibility measurement, efficacy-study design or existing-data review.
Deliver gaps, questions, protocol framework, data dictionary, measurement plan and stage decision criteria.
Qualified review and confirmed delivery arrangements precede human research. Recruitment, execution or a positive finding is not included automatically.

Quoted after scoping. Design depth, outcomes and instruments, record volume, expert time and statistical work affect the fee.
Separate recruitment, product preparation and quality testing, laboratory tests, ethics and execution costs. State whether this phase provides design only.
Agree the design-phase ceiling and milestones before estimating a trial from sample-size and implementation needs. Fees do not depend on significance or sales gains.

Acceptance criteria

Business-experience measures and health outcomes are separated; the primary outcome and timing are prespecified.
Comparator, key confounding, adherence, missingness and adverse experiences are addressed.
Sample-size parameters are sourced or labelled as assumptions. Design, execution and external-cost boundaries enable provider quotations.

Checking the evidence

Gaps are checked against product records, original research and authorised trial-use data. Reviews and behaviour address only the questions actually measured.
Qualified researchers review sample-size assumptions, measurement and comparators. Ethics and human-study implementation responsibilities are agreed separately.

Workflow and inputs

From inputs to delivery

Explore the workflow and deliverable structure. This preview does not run searches, read real records or produce medical findings.

01 / WORKFLOW PREVIEW

Separate the business and health questions

Clarify the decision: usable formula, sustained use or a change in one health-related outcome.

What becomes visible

Primary and secondary questions, distinguishing product experience from effectiveness research.

Methods, sources and professional responsibilities

THE BASIS FOR THIS SCOPE

Why this approach? Inspect the basis.

Check the match between product, population, use conditions and outcomes before defining a supported claim.

OFFICIAL GUIDANCE

FTC · Health Products

Federal Trade Commission · US

Does the research match the product claim?

Scientific support for health-product claims should match the product and claim, rather than merely a similar ingredient.

Scope & access conditions

This is US guidance. Other markets require separate assessment; it is not an approval or compliance conclusion.

Open official source

PUBLIC DATABASE

ClinicalTrials.gov

NLM / NIH

Check studies and reported results

Review study objectives, eligibility, locations, status and reported results, then identify questions for the clinical team.

Scope & access conditions

Sponsors or investigators submit the records. A listing is not government approval of safety or effectiveness, or a determination that you should participate.

Read the official description

Open official source

METHOD REFERENCE

GRADE · Cochrane Handbook

Cochrane · Chapter 14

Show effect size and confidence separately

Present important outcomes, relative and absolute effects, available data and certainty, with reasons for downgrading.

Scope & access conditions

GRADE evaluates a body of evidence for a particular outcome. Database inclusion or one study does not automatically establish high certainty.

Open official source

These references support problem definition and evidence appraisal. Your conclusions still require project-specific sources and professional review.

The value of this commissionEOS maps one finished version, dose, population and claim to locatable evidence and prioritised gaps.

Food and nutrition evidenceCompare alternatives and value

There are many ingredient papers. Do they support this finished product’s specific claim?

What to assess	Exponent	Evidence OS · Commissioned scope
Service focus	Exponent specialises in nutrition-claim substantiation, study planning and regulatory support.	EOS maps one finished version, dose, population and claim to locatable evidence and prioritised gaps.
When to choose	Choose qualified services for submissions, regulatory strategy and study execution.	A pilot may lock one finished version, up to three claims, one population and one use dose; source limits are agreed.

What the fee pays for: Quoted by scope; separate claim review, protocol, analysis and updates from testing, recruitment and execution.
Value beyond this task: Reuse channel Q&A, source indexes and ingredient/product maps; assess formula changes incrementally.
How to assess value: Track unsupported claims revised/withdrawn, repeat-check hours avoided and next-study budgets; measure sales impact separately.

Verify finished-product, population and dose matching plus market review; no guaranteed positive findings or certification.

CHECK THE OFFICIAL SERVICE SCOPEExponent · Claims on Foods and Dietary Supplements

References for research definitions and review methods

These sources inform product, population, use-condition and review definitions. Findings about a particular product require its original research; claims and submission requirements are checked for the target market.

Reuse and updates after delivery

Keep a reusable data dictionary and measurement framework for comparable evaluation of the next version.
Identify unclear questions or unsuitable measurement early, with options to pause, revise or narrow the claim. Practical gains require subsequent real execution.

Agree reuse rights, retention and export periods, and future update fees when scoping.

Questions before commissioning

Can we start with a small trial-use study?

Yes, assess feasibility first. A small, uncontrolled or review-only exercise usually cannot answer a product effectiveness question. Define the recruitment, measurement, variability or adherence parameters it must estimate.

Can you give us a participant count and total cost now?

Define the primary outcome, comparison, expected difference, variability and missingness before calculating sample size and resources. Missing parameters may require pilot measurement; we do not invent a fixed headcount or price.

Can you guarantee an effective result?

Agree a checkable protocol and complete reporting, not a positive result. Unsupported claims must remain unsupported; the next decision may be to narrow the claim or stop investment.

Define the delivery for your actual question.

Add your goal, available inputs and timing. Agree scope, review responsibilities and a quote before commissioning.

Request scope & quote

Explore other situations

Health-consumer products and wellbeing providers

You have ingredient papers. What do they actually show about your finished product?

Receive an ingredient-to-product evidence table, claim boundaries, conflicting findings and gaps, with options to obtain missing records, narrow the claim or study the finished product.

Quoted by scopeSee the deliverable

Health-consumer products and wellbeing providers

Evidence for meditation is not automatically evidence for your app. What is yours missing?

Receive a version-and-content evidence map, measurable support goals, population boundaries, gaps and study-design elements that also track adverse experiences.

Quoted by scopeSee the deliverable

Health-consumer products and wellbeing providers

An employer wants your stress-support service. Can you show what it changes?

Receive a version-specific evaluation design covering users, primary outcome, comparator, timing, service dose and delivery records, with findings separated from purchasing assumptions.

Quoted by scopeSee the deliverable

Health-consumer products and wellbeing providers

You changed the wellbeing device. Does the old evidence still apply?

Receive a version-change table, affected claim evidence, reasoned transferability assessment and next steps for bench, usability, experience or human comparison studies.

Quoted by scopeSee the deliverable

Health-consumer products and wellbeing providers

People love the experience. What does your wellbeing service actually provide?

Receive a version-specific question, measurable experience and support outcomes, relevant and inapplicable research, risk/adverse-feedback records and a staged evaluation plan.

Quoted by scopeSee the deliverable

Health-consumer products and wellbeing providers

Your product is preparing for agent-assisted procurement, but its health claims lack a verifiable evidence dossier.

Within an agreed scope, receive a machine-readable JSON dossier, a readable product explanation, a claim-to-source table and an evidence-gap list, with product versions, evidence dates, human-review and disclosure status.

Quote after scope confirmationSee the deliverable

Health-consumer products and wellbeing providers

Several health products claim to work. Before procurement, you need to know whose evidence fits your customers.

Receive a supplier-evidence comparison, source and missing-data records, comparison JSON, disagreement notes and a study-gap list. Agreed humans review the materials; authorised staff separately decide purchasing conditions, ranking criteria and orders.

Quote after scope confirmationSee the deliverable