RWE · Data · Platforms

Building real-world evidence, without drowning in the data.

Real-world data is everywhere, but scattered and messy. Advanced digital platforms turn registries, ePRO and connected-device streams into evidence you can actually use. Here is how.

Real-world dataePRO & registriesEU MDR PMCFData quality
How digital platforms make real-world evidence easier to build, Eclevar MedTech

European Champion

Platinum Award 2026

Eclevar MedTech & Milo Health · xShare × EUCROF Open Call

Led by authority

Platforms plus method.

A platform does not make evidence; a method does. Ours combines the technology with the scientific rigour a reviewer expects.

Sébastien Meier

Sébastien Meier

Chief Data Officer · Biometry · 30 yrs

Endpoints, statistics and RWE; architect of the MILO EDC, 21 CFR Part 11 and real-time dashboards.

Charline Petitdemange

Charline Petitdemange

Lead Clinical Project Manager

ISO 14155 study conduct, EUDAMED registration and multi-country site monitoring across Europe.

Real-world dataePRO / registriesGDPREU MDR PMCF

Awards, funding, accountability

Europe’s best-rated medical device CRO.

Platinum Award 2026

Platinum Award 2026

Top tier at the xShare × EUCROF Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at EUCROF 2026 in Amsterdam.

The announcement →

Co-funded by the European Union

Selected through the xShare Open Call for clinical research innovation, Horizon Europe.

xShare results →

Independently reported

Distinction confirmed by an independent third party, the CVBF, also an awardee of the xShare × EUCROF Open Call.

CVBF coverage →

The problem

The bottleneck is not data, it is usable data.

Real-world data exists in abundance, but in incompatible formats and variable quality. A digital platform’s value is turning that into a compliant, analysis-ready evidence base.

01

Why RWE is hard to build

Real-world data sits in registries, electronic health records, ePRO tools and connected devices, each with its own format, coding and quality. Assembling it into an analysis-ready dataset, with provenance and governance intact, is where most real-world evidence projects stall.

02

What a good platform does

A capable platform removes the friction between raw data and evidence.

Platform capabilities

  • Connecting multiple sources into one governed dataset
  • Standardising and validating data as it arrives
  • GDPR-compliant pseudonymisation and access control
  • Analysis-ready exports with a clear audit trail

03

Where it pays off

For EU MDR, the biggest payoff is PMCF: a platform that continuously assembles real-world data makes proactive post-market evidence feasible instead of a periodic scramble. It also strengthens market-access and reimbursement dossiers that increasingly demand real-world outcomes.

04

Technology is half the answer

A platform accelerates the mechanics, but the evidence still has to be scientifically sound: the right data sources, defined endpoints and a defensible analysis. We pair the platform with the study design and biostatistics that make the output credible to a Notified Body.

RWE, made usable

From raw data to evidence.

Many sources
one dataset
Validated
on arrival
GDPR
by design
PMCF
made feasible

Talk to a specialist

Struggling to turn real-world data into evidence?

Book a free scoping call. We combine the right platform with sound study design so your real-world evidence holds up for PMCF and market access.

Book a free scoping call

Real-world data is not real-world evidence until someone builds it.

An expert read pairs the right digital platform with defensible study design, turning scattered real-world data into evidence a Notified Body accepts.

Book a free scoping call

Questions we hear first

Digital platforms for RWE, answered.

Why is real-world evidence hard to build?
Because real-world data sits in registries, electronic health records, ePRO tools and connected devices, each with its own format, coding and quality, and assembling it into an analysis-ready dataset with provenance intact is where most projects stall.
What does a good RWE platform do?
It connects multiple sources into one governed dataset, standardises and validates data on arrival, applies GDPR-compliant pseudonymisation and access control, and produces analysis-ready exports with a clear audit trail.
Where does a platform pay off most?
In EU MDR PMCF, where continuously assembled real-world data makes proactive post-market evidence feasible, and in market-access and reimbursement dossiers that increasingly demand real-world outcomes.
Is the platform enough on its own?
No. A platform accelerates the mechanics, but the evidence still requires the right data sources, defined endpoints and a defensible analysis, so the technology must be paired with sound study design and biostatistics.

Reforming Clinical Evaluation of Medical Devices in Europe