Notes from the work.
Insight on Direct-to-Participant and decentralised trials, real-world evidence, AI governance and the science behind better health decisions - plus where we’re presenting, what we’re publishing and what’s new at Evidilya.
Where to find us
Congresses and meetings we're attending next.
Upcoming events, list view
- 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.
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.
Read
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.
D-T-P enters the guideline: from pioneer practice to regulatory default
In twenty-four months, direct-to-participant research has moved from 'innovation' to the way GCP is now written. A short reading of the FDA final DCT guidance and ICH E6(R3) with its Annex 2.
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.
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.
Notes
Short archive pieces, field notes and brief reflections, collected here.
- Insight
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.
Read - EventRecap
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.
ReadCPHI Frankfurt 2025 - Insight
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.
Read - Insight
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.
Read - Insight
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.
Read - Insight
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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Scientific publications available on request.