Éclairages issus de notre pratique.
Des analyses sur les études Direct-to-Participant et décentralisées, les données de vie réelle, la gouvernance de l’IA et la science au service de meilleures décisions en santé, ainsi que nos prochains rendez-vous et publications.
Où nous rencontrer
Les congrès et rencontres auxquels nous participerons prochainement.
Événements à venir, vue en liste
- Evidilya at EADV Congress 2026: dermatology evidence beyond the trial site — 3 oct. 2026 — Vienna, 30 September – 3 October.
- Meet Evidilya at CPHI Milan 2026 — 8 oct. 2026 — 6 – 8 October, Fiera Milano.
- Meet Evidilya at Fi Europe 2026, Frankfurt — 19 nov. 2026 — 17 – 19 November, Messe Frankfurt.
Quatre articles sélectionnés pour le marché francophone sont disponibles en français. Les autres sont présentés en anglais et clairement signalés comme tels.
Essai clinique, RWE ou Health Scientific Survey : choisir le bon niveau de rigueur avant de s’engager
Deux erreurs symétriques coûtent le plus cher aux sponsors : présumer qu’une enquête couvrira tout, ou construire un protocole complet pour une question à laquelle un instrument agile aurait pu répondre. C’est la nature des données à recueillir qui détermine la voie à suivre, pas le budget.
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En bonne santé, à risque, malades : pourquoi la recherche en nutrition et CHC exige une cartographie de recrutement plus large
Les études en nutrition et en consumer health traversent habituellement trois états de santé, sains, sub-sains et malades, et chacun exige un canal différent. N'en atteindre qu'un seul restreint la portée scientifique.
Le D-T-P entre dans les lignes directrices : d’une pratique pionnière au standard réglementaire
En vingt-quatre mois, la recherche direct-to-participant est passée du statut d’« innovation » à celui de norme d’écriture des BPC. Une lecture brève de la guidance finale de la FDA sur les DCT et de l’ICH E6(R3) avec son annexe 2.
Les allégations nutritionnelles exigent des preuves humaines : la voie alignée sur l’EFSA
Petites tailles d’effet, variabilité biologique et consommation réelle non supervisée rendent la justification des allégations nutritionnelles réellement difficile. À quoi ressemble un programme aligné sur l’EFSA, et où la plupart échouent.
Synthetic control arms: from pioneering to emerging regulatory precedent
Externally-controlled and synthetic-arm designs have moved from pioneering to structured regulatory openness. What the guidance actually asks for, and where the method still does not hold.
Verifiability over explainability: how to govern AI in evidence generation
The useful question for clinical AI is not how the model learned, but whether its outputs can be verified, stress-tested and reproduced. A governance stance that matches what the EU AI Act and FDA now ask for.
Beyond consent-centric: what EHDS and governed reuse change for evidence
Governance of health data is moving from the signature on a consent form to a system of institutional guarantees. What the European Health Data Space actually changes for secondary use, and what it demands in return.
Pharmacy-based research: reaching consumers where they actually buy
For non-Rx consumer health and nutrition, the community pharmacy is not a fallback site. It is frequently the only setting where the intended user can be reached under real conditions of use.
Post-market clinical follow-up under EU MDR: from obligation to strategic asset
PMCF has outgrown its reputation as a formality. How manufacturers are turning real-world safety and performance data into intended-purpose extensions, competitive positioning, and dossiers regulators want to read.
Not a butterfly effect: why small nutritional shifts carry the largest returns
The idea that small changes can have outsized effects on health is true – but the butterfly is the wrong metaphor. The real science is about compounding, not chaos, and it comes with a catch that every nutrition and consumer-health sponsor eventually runs into: the smaller the effect, the harder it is to prove.
AI in clinical research: from acceleration to methodological rigour
Synthetic control arms, cohort selection, risk-based monitoring: AI is already inside modern trials. Where EMA, FDA and the EU AI Act are drawing the line, and what CROs are expected to validate before letting a model near a protocol.
Notes
Brèves notes d’archives, observations de terrain et réflexions.
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Real-world evidence in 2026: from post-approval safety to strategic decisions
RWE has moved well beyond post-approval monitoring. Where regulators and industry now accept real-world data to inform design, comparators and access, and where the limits still sit.
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Evidilya at CPHI Frankfurt 2025: decentralised trials and the phygital model
28 – 30 October, Messe Frankfurt. A recap of our conversations on how PHYGITAL-CROWD and ECS® compress the path from protocol to proof in decentralised and virtual settings.
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The evolution of RWE studies in the modern era
From retrospective audits to continuously governed real-world programmes: how RWE grew up in the last decade, and what modern evidence looks like.
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The path to long-term weight management: challenges and solutions
GLP-1s changed the pharmacology; adherence, tolerability and lifestyle context now decide long-term outcomes. Where evidence generation has to catch up.
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Technology and data robustness in neuroscience research
Cognitive and neurological endpoints are notoriously noisy. Digital biomarkers, remote assessment and standardised capture are quietly redefining what 'robust' means.
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Revolutionising oncological studies with decentralised approaches
Cancer trials are among the hardest to decentralise, and among the most valuable to try. What is safely remote, what stays at the site, and how to design the interface.
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Publications scientifiques disponibles sur demande.