Erkenntnisse aus unserer Arbeit.
Einblicke zu Direct-to-Participant und dezentralen Studien, Real-World-Evidenz, AI-Governance und der Wissenschaft hinter besseren Gesundheitsentscheidungen – ergänzt um Veranstaltungen, Publikationen und Neues von Evidilya.
Wo Sie uns finden
Kongresse und Treffen, an denen wir demnächst teilnehmen.
Bevorstehende Veranstaltungen als Liste
- Evidilya at EADV Congress 2026: dermatology evidence beyond the trial site — 3. Okt. 2026 — Vienna, 30 September – 3 October.
- Meet Evidilya at CPHI Milan 2026 — 8. Okt. 2026 — 6 – 8 October, Fiera Milano.
- Meet Evidilya at Fi Europe 2026, Frankfurt — 19. Nov. 2026 — 17 – 19 November, Messe Frankfurt.
Vier für den deutschen Markt ausgewählte Beiträge sind auf Deutsch verfügbar. Weitere Beiträge erscheinen darunter auf Englisch und sind deutlich gekennzeichnet.
D-T-P erreicht die Leitlinie: von der Pionierpraxis zum regulatorischen Standard
Innerhalb von vierundzwanzig Monaten ist die Direct-to-Participant-Forschung von der „Innovation“ zu dem geworden, wie GCP heute geschrieben wird. Eine kurze Lektüre der finalen FDA-Guidance zu DCT und von ICH E6(R3) mit seinem Annex 2.
Lesen
Post-Market Clinical Follow-up unter der MDR: von der Pflicht zum strategischen Aktivposten
PMCF hat den Ruf der reinen Formalität abgelegt. Wie Hersteller Real-World-Daten zu Sicherheit und Leistung in Erweiterungen der Zweckbestimmung, Wettbewerbspositionierung und Dossiers verwandeln, die Zulassungsbehörden gerne lesen.
Trial, RWE or scientific survey: choosing the right rigour path before you commit
Two symmetric mistakes cost sponsors the most: assuming a survey will cover everything, or building a full protocol for a question an agile instrument could have answered. The route is decided by the data you intend to capture, not by budget.
Healthy, sub-healthy, diseased: why nutrition and CHC research needs a wider recruiting map
Nutrition and consumer-health studies routinely span three health states, healthy, sub-healthy and diseased, and each needs a different channel. Reaching only one narrows the science.
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.
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.
Nutrition claims need human evidence: the EFSA-aligned path
Small effect sizes, biological variability and unsupervised real-world consumption make nutrition claims genuinely hard to substantiate. What an EFSA-aligned programme looks like, and where most fail.
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.
Notizen
Kurze Archivbeiträge, Feldnotizen und Reflexionen.
- Einblick
Real-World-Evidenz 2026: von der Überwachung nach der Zulassung zu strategischen Entscheidungen
Real-World-Evidenz ist längst über die Überwachung nach der Zulassung hinausgewachsen. Die Fälle, in denen Zulassungsbehörden und Industrie heute Real-World-Daten akzeptieren, um Studiendesign, Vergleichsarme und Market Access zu stützen – und die Grenzen, die bestehen bleiben.
Lesen - Einblick
Technologie und Datenrobustheit in der neurowissenschaftlichen Forschung
Kognitive und neurologische Endpunkte gelten als besonders verrauscht. Digitale Biomarker, Fernbeurteilung und standardisierte Erfassung definieren still und leise neu, was „robust“ bedeutet.
Lesen - VeranstaltungRückblick
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.
LesenCPHI Frankfurt 2025 - Einblick
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.
Lesen - Einblick
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.
Lesen - Einblick
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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Wissenschaftliche Publikationen sind auf Anfrage erhältlich.