For MedTech teams who need consistent on-site and remote oversight that meets ISO 14155, EU MDR and UKCA expectations, without overwhelming investigators and site staff.
On-site and remote monitoring are part of Eclevar's full clinical trial monitoring services under ISO 14155, including risk-based monitoring and source data verification.
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
Device leaders rely on Eclevar for on-site and remote monitoring across Europe. Read all client success stories.
Monitoring exists to protect patients and keep data reliable. Under the eye of a former TÜV SÜD reviewer, our CRAs combine on-site and remote review to confirm protocol adherence, verify critical data and give you visibility from First Patient In to database lock, with an audit trail Notified Bodies expect.
A monitoring strategy focused on the critical data and processes that impact patient safety.
Visit reports filed in the Trial Master File, documenting protocol adherence and findings.
Continuous remote review with analytical notes on trends, outliers and site performance.
A live tracker within MILO EDC, with root cause analyses and CAPA for critical issues.
An inspection-readiness summary consolidating monitoring evidence for the Notified Body.
Establish the monitoring strategy through a risk-based monitoring plan.
Prepare sites and systems with Site Initiation Visits and EDC training.
Execute on-site and remote monitoring through our Clinical Research Associates.
Finalise and prepare for inspection with Close-Out Visits.
A growing company lacked the in-house CRA capacity to cover its sites consistently.
Outcome: consistent, local monitoring coverage without adding headcount.An established manufacturer running a PMCF study needed dependable oversight and clean data.
Outcome: reliable data and a defensible audit trail for the Notified Body.A non-European company was unfamiliar with EU monitoring standards and expectations.
Outcome: ISO 14155 aligned monitoring that met EU inspection expectations.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, useful for any monitoring and data integrity plan.
Eclevar manages RegenLab's PMCF programme on chronic wound devices. This is 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, from protocol design through to final study report.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
Risk-based monitoring focuses oversight on the critical data and processes that directly impact patient safety, using a smart mix of targeted on-site visits and continuous remote review.
Yes, using central data review and remote source data verification where permitted.
Yes. We deploy local, in-house CRAs across EU and UK territories with local language proficiency.
Every deviation is logged in a live tracker; critical issues receive root cause analyses and CAPA implementation.
Protocol adherence and data integrity documentation provide the audit trails Notified Bodies expect at inspection.
Book a short call with our clinical operations team to review your protocol and design a monitoring strategy that guarantees data integrity.
Book a consultation