Clinical / Efficacy Study Data Extraction
Turn a personal-care efficacy study report into a clean, cited read-out - design, endpoints, statistics vs baseline and between treatments, and whether each claim is substantiated.
Manual re-keying of each contract-lab study report into a claims read-out - normally done by hand across many differing lab and endpoint formats - compressed into a single cited, significance-checked run
per study report
What it extracts
13 extraction fields
- Study Overview
- The one-look roll-up - study title and identifier, type/design, body site tested, product category, and whether the report is preliminary or final - so a reviewer can orient before reading detail.
- Study Design & Methodology
- The design that determines how much weight the results carry - control/comparator type, blinding and randomization, enrolled and completed panel size, demographics, duration, measurement timepoints, application regimen, and test conditions.
- Test Products & Treatment Codes
- Every test material and comparator with its blinded treatment code, batch/lot, and role (test / benchmark / vehicle-placebo / untreated / baseline); a swapped code invalidates the whole read-out.
- Efficacy Endpoints & Instruments
- Each endpoint the study measured and how - parameter, method/instrument (TEWL, corneometry, cutometry, profilometry, gravimetric sweat, grading), assessment type, timepoints, and whether it is primary or secondary.
- Statistical Method Summary
- The statistical approach - test(s) used, significance threshold (alpha, default 0.05), tail, multiplicity adjustment, analysis population, and software - so significance is judged consistently.
- Endpoint Results vs Baseline
- Within-treatment results vs baseline (T0) per treatment x endpoint x timepoint - mean, change and percent change vs baseline, standard error, p-value, and a significance flag - the effect the product produced on its own.
- Between-Treatment Comparison
- Head-to-head comparisons (test vs vehicle/control/benchmark) per comparison x endpoint x timepoint - difference, standard error, t-value, DF, p-value, and significance - the basis for comparative and superiority claims.
- Overall Efficacy Significance
- The single call on the primary endpoint - significant efficacy demonstrated, directional trend only, no significant effect, or inconclusive - read from the vs-baseline and between-treatment results against the study's alpha.
- Claim Support Assessment
- The evidence chain - each proposed claim tied to a specific endpoint, comparison basis, and p-value, rated Fully / Conditionally / Not supported per claim-substantiation best practice.
- Claims Substantiated
- The go/no-go gate - true only when at least one primary efficacy claim is backed by a statistically significant result on the appropriate comparison basis.
- Protocol & Ethics Compliance
- The protocol and ethics footprint that makes the study defensible - protocol/SOP and guideline followed, ethics/IRB review, informed consent, adverse events, and any GCP / data-integrity statement.
- Data Integrity Validation
- The consistency checks an analyst runs before trusting the read-out - completers <= enrolled, significance flags match p-values, percent change ties to the means, claims tie to significant results, timepoints agree, and sample size is adequate - each Pass / Fail / Review.
- Study Findings Summary
- The analyst narrative - design and panel, the key significant findings and their magnitude on the correct basis, the overall call and whether any claim is substantiated, and any integrity flags to resolve before relying on the study.
Where it fits
Cosmetic / personal-care efficacy testing and claim substantiation
Upstream
A study is designed and run - in-house or at an external contract testing lab - and the lab returns a preliminary or final results report (instrumental read-outs, statistical tables, clinical grading, or consumer-perception data) by email, portal, or shared drive
This step
Study-report data extraction and claim-support assessment
Downstream
- Product Claims & Concept Development
- Regulatory / claims sign-off and Product Information File
- R&D formulation decisions and go/no-go
- Marketing pack and advertising copy
What it needs
Documents
- Preliminary or final efficacy study report
- Instrumental study read-out (TEWL, corneometry, cutometry, profilometry, gravimetric sweat, etc.)
- Statistical results tables (t-test / ANOVA output)
- Clinical-grading / expert-assessment report
- Consumer-perception (self-assessment) study report
- Study protocol or test method
Systems
- Contract-lab portal
- SharePoint
- Google Drive
Prerequisites
- The study report (preliminary or final)
- The treatment-code key (which blinded code is which formulation), if separate
- The proposed claims the study is meant to support, if a claim check is wanted
What it produces
A cited study read-out - design and panel, test products by treatment code, endpoints and instruments, results vs baseline and between treatments with p-values and significance flags, an overall efficacy call, a claim-to-result support assessment, a claims-substantiated gate, protocol/ethics footprint, and data-integrity checks
Delivered to
- Claims substantiation dossier / Product Information File
- R&D study database or tracker
- Claims and concept-development workflow
Review model
A claims-substantiation scientist or study manager reviews the flagged significance calls, the claim-to-result evidence chain, and the data-integrity checks before any benefit is treated as substantiated. The overall-significance and claims-substantiated judgments are confirmed against the primary endpoint and the correct comparison basis before use.
Who uses it
Volume fit
Works best for
R&D and claims teams processing many efficacy study reports a month across varied endpoints, instruments, and external-lab report formats
Too small for
a one-off review of a single well-understood study
Grounded in
- Regulation (EU) No 655/2013 - common criteria for cosmetic product claimsverified as of 2026-07-22
- Cosmetics Europe - Guidelines for Cosmetic Product Claim Substantiationverified as of 2026-07-22
- FDA Antiperspirant Drug Products for OTC Human Use - Final Monograph (21 CFR Part 350)verified as of 2026-07-22
- Declaration of Helsinki / ICH E6 Good Clinical Practice (ethical conduct of human studies)verified as of 2026-07-22
Changelog
- July 2026
based on a production deployment at a global consumer personal-care company
Related agents
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Pressure-test a consumer / personal-care product concept and its marketing claims: break the concept into insight, benefit, reason-to-believe, and positioning; inventory every express and implied claim; link each to a substantiation basis; test claim-to-evidence adequacy against FTC, NAD, and EU 655/2013; flag overclaiming; and return a cited claims-substantiation matrix, a readiness call, and a finalised concept summary.
Skin-Image Measurement (Vision)
Turn a personal-care study's standardized skin photographs into clean, cited per-image measurements and change vs baseline - wrinkles, spots, pores, redness, texture, radiance, or perceived age - with a capture-quality gate on the front.
Consumer Complaint Analysis
Triage a consumer personal-care product complaint into a clean, cited record - category, product and batch, adverse-event and seriousness assessment, a MoCRA / EU cosmetovigilance reportability screen, root-cause signals, and recommended actions.
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