RPM · Connected · Data

Remote patient monitoring, rigorous, not just convenient.

RPM promises continuous, real-world data and lighter site burden. The trade-off is data governance and compliance. Here is how to get the benefit without the risk.

Connected devicesISO 14155GDPRReal-world data
Remote patient monitoring in device clinical trials, Eclevar MedTech

European Champion

Platinum Award 2026

Eclevar MedTech & Milo Health · xShare × EUCROF Open Call

Led by authority

Continuous data, controlled properly.

RPM generates a flood of data. The value is in governing it, which is where our data team lives.

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.

Connected devicesISO 14155GDPRValidated data

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 approach

The promise and the trade-off.

Remote patient monitoring uses connected devices and apps to capture data between or instead of visits. Done well it improves retention and richness; done badly it creates ungovernable data.

01

What RPM brings

RPM captures continuous, real-world physiological and behavioural data from the patient’s own environment, reducing site visits and revealing patterns a periodic visit would miss. For long follow-up and PMCF it can transform retention.

02

The trade-offs

The cost is complexity.

What you take on

  • Device validation and data provenance for every connected source
  • Missing-data handling when patients or devices disconnect
  • Data volume that needs a plan, not just a database
  • Patient burden and adherence with wearables

03

Compliance

RPM data is still trial data: it must meet ISO 14155 for GCP, and GDPR for continuous health-data collection, with clear consent for the monitoring, pseudonymisation and compliant hosting. The connected devices themselves need documented validation.

04

Doing it well

The winning approach is selective: use RPM for the endpoints where continuous data adds real value, keep controlled measurement for the primary endpoint, and run it on a validated platform. We match the monitoring to the science, not the hype.

RPM at a glance

Rich data, governed.

Continuous
real-world data
ISO 14155
still applies
GDPR
continuous consent
Selective
match to endpoints

Talk to a specialist

Could RPM strengthen your study, or complicate it?

Book a free scoping call. We tell you where remote monitoring adds real value and how to keep it compliant and governable.

Book a free scoping call

Continuous data is only an asset if you can govern it.

An expert read tells you where RPM adds value, what validation and GDPR steps it needs, and how to keep the primary endpoint controlled.

Book a free scoping call

Questions we hear first

Remote patient monitoring, answered.

What is remote patient monitoring in a clinical trial?
RPM uses connected devices and apps to capture continuous, real-world physiological and behavioural data from the patient’s own environment, reducing site visits and revealing patterns a periodic visit would miss.
Does RPM data have to meet ISO 14155 and GDPR?
Yes. RPM data is trial data: it must meet ISO 14155 for Good Clinical Practice and GDPR for continuous health-data collection, with clear consent, pseudonymisation and compliant hosting, and the connected devices need documented validation.
What are the main trade-offs of RPM?
Complexity: device validation and data provenance, handling missing data when patients or devices disconnect, managing large data volumes, and maintaining patient adherence with wearables.
When should RPM be used?
Selectively, for the endpoints where continuous data adds real value and for long follow-up and PMCF, while keeping controlled measurement for the primary endpoint.

Reforming Clinical Evaluation of Medical Devices in Europe