Substantiation at consumer speed.
Studies for supplements, self-care and OTC, where recruitment speed and real-world data decide the timeline, and where Evidilya already delivers.
Claims need evidence, and the market moves fast.
Consumer health sponsors must substantiate claims credibly, fast and within tight budgets, across healthy, sub-healthy (subclinical, at-risk, self-perceived) and diseased consumers, each reached through a different channel. Traditional sites see almost none of them, and slow recruitment quietly kills the timeline.
The proof engine for consumer health.
- Substantiation studiesDefensible evidence for claims, captured in real conditions of use.
- Efficacy, safety & product vigilanceHuman efficacy, safety, tolerability and cosmetovigilance / product safety surveillance for supplements, self-care and OTC products.
- Wider recruiting mapHealthy, sub-healthy and diseased consumers reached through pharmacies, HCPs, digital communities and PHYGITAL-CROWD.
- Real-world captureePRO and eDiary via LucaH® capture habits in everyday settings.
- Pharmacy & online activationStudies run through community and online pharmacies and territorial HCPs, alongside GCP centres.
- Ethical campaignsRegulation-aligned recruitment consumer brands can stand behind.
The scientific rationale.
- Consumer-health claims stand up to scrutiny when they rest on credible human evidence from real use.
- Real-world use differs from controlled conditions, so real-world data is decisive.
- Post-market evidence supports sustained positioning and consumer trust.
Right-sized designs for credible, fast substantiation.
Interventional evidence
- Randomised and pragmatic substantiation studies
- Efficacy, safety and tolerability studies
- Consumer-perception and usage designs
Observational & epidemiological
- Real-world use-pattern and adherence studies
- Prospective consumer cohorts
- Post-market surveillance and cosmetovigilance / product vigilance for self-care and OTC products
The proof engine for the whole continuum.
- This is where Evidilya's recruitment advantage is most visible: studies convert fastest.
- People-centered capture surfaces the motivations behind everyday health behaviour.
- The same ecosystem scales these studies up into RWE and regulated research.
- Multi-country consumer reach through our communities.
Beyond hospital centres.
For non-Rx consumer health, we activate studies through community and online pharmacies and territorial HCPs, reaching consumers where they actually buy and use products.
Evidence that reflects how people actually live.
We design evidence against the framework that regulates your claim.
The design of a study, endpoints, population, comparator, statistical plan, is a function of which authority will read the evidence. We start there.
- EFSA · Reg (EC) 1924/2006Health claims on foods & food supplements
Applies to consumer-health products marketed as foods, botanicals, probiotics, functional nutrients.
EvidenceHuman intervention studies; characterised ingredient; specified target population. - MDR 2017/745 · Regulation (EU)Consumer-health medical devices (Class I–III)
Devices marketed OTC, thermometers, patches, digital-health, medicated devices.
EvidenceClinical Evaluation Report, PMCF, real-world performance and safety. - MHRA · TGA · FDA OTC monographOTC medicines, self-care
Switch, category expansion, new indications and post-market surveillance for OTC medicines.
EvidenceActual-use studies, label comprehension, self-selection, PASS/PAES designs. - ASA · CAP Code / FTC Act §5Advertising substantiation, UK & US
Consumer-facing claims on efficacy, tolerability and comparative benefit.
EvidenceHuman data mapped 1:1 to the exact wording of the claim.
Before a trial, a survey is often enough.
Validated instruments on habits, adherence and perceived benefit, fielded across consumers and HCPs, to sharpen claims and study design before committing to a full protocol.
Evidence builds medical equity, and the right to talk to clinicians.
In consumer health and nutrition, evidence is a growth asset as much as a regulatory one. It earns HCP attention, opens scientific dialogue and lets the brand carry new medical content into practice, starting a category conversation.
Medical equity
A defensible body of evidence that positions the product inside a clinical conversation.
Scientific authority
Peer-reviewed publications, congress data and KOL endorsement that let the brand co-author the category narrative.
HCP engagement licence
Evidence medical affairs, MSLs and reps can actually share, turning detailing into education HCPs read, cite and recommend.
Delivered through AIRA, advisory boards & KOL and publication & scientific communication.
One study, three health states.
Unlike prescription drug trials, nutrition and consumer-health research routinely spans healthy, sub-healthy (subclinical, at-risk, borderline, self-perceived) and diseased participants. Each state has its own eligibility criteria, endpoints, ethics posture, and, critically, its own recruiting channel. Reaching only one of them narrows the science.
Across the age continuum too, from paediatric cohorts and care-partners to adults and seniors, with age-appropriate consent, endpoints and, where needed, proxy access on ECS® so a trusted caregiver can complete tasks on the participant's behalf.
Substantiate everyday benefit, tolerability, preference and habit-of-use.
General adult consumers · athletes · targeted diets · early-life & healthy ageing.
Digital communities · PHYGITAL-CROWD · online pharmacies · at-home / D-T-P with nurse visits.
Show effect on subclinical, at-risk or self-perceived conditions where a drug is not indicated.
Borderline dyslipidaemia · low-grade fatigue · digestive discomfort · perimenopause · sarcopenic-obese · IBS-lite · mild sleep or mood complaints.
Community & online pharmacies · territorial HCPs · digital communities · patient-like associations.
Generate regulatory-grade evidence for FSMP, medical foods, adjuvant CHC or condition-specific claims.
Diagnosed patients on chronic therapy · rare metabolic disorders · post-acute or recovering populations.
GCP sites · specialist HCPs · patient associations · hospital pharmacies · home visits.
Six channels, one operating layer.
PHYGITAL-CROWD activates the right mix per protocol, orchestrated on ECS® so provenance, consent and audit travel with the participant.
- GCP sites
- Community & online pharmacies
- Territorial HCPs
- Patient associations
- Digital communities · PHYGITAL-CROWD
- At-home · D-T-P & home visits
Substantiate your next claim.
Tell us the claim you need to defend. We'll design the study that gets you there, at consumer speed, with clinical rigour.