A well-built eCRF decides your study’s data quality. On the MILO EDC platform we capture study data in a structured, validated and ISO 14155 compliant way.
Platinum Award 2026
Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Leading device manufacturers choose Eclevar for clinical evidence and real world evidence. Read all client success stories.
Dr Mark Da Costa, COO and former TÜV SÜD reviewer, knows a study is judged by its data. We build eCRFs with built-in edit checks and a complete audit trail, so the data holds up under review.
Data-quality problems are hard to fix after the fact. A well-designed eCRF with built-in edit checks prevents errors at the point of entry.
The MILO EDC platform combines structured data capture, query management and a full audit trail into a compliant, review-ready dataset.
An EDC environment tailored to medical device studies.
Forms tailored to the protocol and endpoints.
Edit checks and query management for clean data.
21 CFR Part 11, ISO 14155 and GDPR compliant.
Eclevar deploys in-house Clinical Research Associates in the United Kingdom, Germany, France and Sweden, ensuring smooth study initiation, ethics-committee submissions (for example CPP in France) and high-quality clinical data collection.
The platform is one half of the answer. eCRF design for medical devices is the other: the build, the edit checks and the validation are delivered by our data management team.
Building and validating the study database.
Query management, coding and consistency checks.
Controlled database lock for analysis.
Completeness, consistency and accuracy of the data.
A complete audit trail for every change.
21 CFR Part 11, ISO 14155 and GDPR.
Low burden for the investigational sites.
Secure, GDPR-compliant data hosting in the EU.
A clean dataset for biostatistics.
Data quality means completeness, consistency and accuracy across all investigational sites.
Assessing data-source quality, completeness and consistency.
A robust protocol aligned with ISO 14155:2026 and GCP.
Site activation, in-house CRAs, high-quality data collection.
Rigorous statistical analysis of safety and performance.
Comprehensive reports for Notified Body and authorities.
RegenLab needed PMCF data to renew its CE marking without disrupting clinical workflows. Eclevar designed a targeted RWE-PMCF registry study on the MILO EDC platform, capturing wound-healing trajectories and adverse-event tracking.
Multicentre study with retrospective and prospective record data from French university hospitals (CHU Valenciennes, Nantes, Brest), covering carotid and femoral locations up to 3 years post-op and meeting EU MDR requirements for CE certification.
Whitepapers, client testimonials and publications produced by our teams and partners (BSI, TÜV SÜD, RegenLab).
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, relevant to any clinical program.
Eclevar manages RegenLab's PMCF program on chronic wound devices: a randomized study of 160 patients across 14 sites in 5 EU countries, covering both diabetic foot ulcer (DFU) and venous leg ulcer (VLU) indications. The partnership combines Eclevar's ISO 14155 clinical expertise with the Milo Studio platform to deliver post-market clinical follow-up evidence that supports both Notified Body scrutiny and reimbursement endpoints.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
An electronic Case Report Form through which study data are captured in a structured, validated way.
Yes, it meets 21 CFR Part 11, ISO 14155:2026 and the GDPR, with a complete audit trail.
They prevent implausible or incomplete entries at the point of capture and reduce downstream queries.
In a secure, GDPR-compliant environment within the EU.
Yes, we migrate existing forms and data into the MILO EDC platform.
Talk to our team about eCRF design, the MILO EDC platform and data management that holds up under review.
Book a free callFrom AI-powered patient recruitment to real-time data analytics, Milo Healthcare streamlines every aspect of your clinical trials while ensuring full regulatory compliance.
Easy to manage your data
Collaborate securely
Accelerate your clinical research
Finalization of the eCRF
Faster Cleaned Data
Simplified Export of CERs
Collect scientifically valid PMCF data that complies with the MDR using our platform.
