Monitoring is where data integrity and patient safety are won or lost. Eclevar runs on-site, remote, centralised and risk-based monitoring for medical device investigations under ISO 14155, with in-house CRAs in seven countries and former Notified Body reviewers designing every monitoring plan.
In-house CRAs · 7 countries
One accountable team runs your site visits, source data verification and centralised review, on the MILO Studio platform that won the Platinum Award at the xShare & EUCROF 2026 Open Call.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders across cardiovascular, orthopaedics, wound care and more choose Eclevar. Read all client success stories.
Clinical trial monitoring is the independent oversight of a clinical investigation that protects participant safety and guarantees the data are complete, accurate and verifiable against source.
For medical devices, monitoring is governed by ISO 14155 and EU MDR 2017/745, not the pharma ICH-GCP framework. A clinical research associate (CRA) confirms that the investigation is run to the protocol, that informed consent is valid, that adverse events and device deficiencies are reported, and that every critical data point in the eCRF matches the source document at the site.
Modern monitoring is not a stack of 100% on-site visits. It combines on-site monitoring, remote monitoring, centralised statistical review and risk-based monitoring (RBM), concentrating effort on the sites and data that carry the most risk to safety and to the primary endpoint. Done well, it is the difference between a trial master file that survives a Notified Body inspection and one that unravels under it.
Eclevar delivers monitoring as one connected service across the clinical investigation lifecycle, feeding the clinical evaluation report and the post-market clinical follow-up that keep a CE certificate valid.
Eclevar's model brings the regulatory perspective inside the CRO, eliminating the gap between what manufacturers submit and what assessors expect. Dr Mark DaCosta, COO and former TÜV SÜD reviewer, and Dr Nikhil Khadabadi, CMO for orthopaedics and spine and also a former TÜV SÜD senior reviewer, lead a team that designs clinical evidence exactly the way Notified Bodies expect to read it, from the first protocol version.
Who monitors your trial, and how, decides whether your data survives inspection. The gap between a subcontracted CRA network and an in-house, risk-based team is structural.
From the first site initiation visit to close-out and independent audit, every monitoring activity is run to ISO 14155 and captured with full traceability for Notified Body inspection.
Qualification and initiation visits that confirm each site is trained, equipped and compliant before the first patient, tied to our feasibility and site selection.
Scheduled on-site and remote visits verifying consent, eligibility, protocol compliance, device accountability and adverse-event reporting.
Targeted, risk-based verification that critical data in the eCRF match source, run on MILO Studio rather than 100% blanket SDV.
Off-site review of certified copies plus statistical central monitoring that detects outliers, trends and site risk across the whole dataset in real time.
A monitoring plan that concentrates effort on the critical data and highest-risk sites, the approach ISO 14155 explicitly encourages for device trials.
Close-out visits, trial master file reconciliation and independent audit for inspection readiness, backed by our ISO 13485 quality system.
One accountable team covers every stage of the clinical investigation lifecycle, so nothing is lost between a protocol, a monitoring visit and a Notified Body submission.
Pre and post-market trials under ISO 14155, from feasibility and site selection and study initiation through multi-country ethics submissions and on-site and remote monitoring.
The clinical evaluation report under MDCG 2020-6, PMCF Plans and SSCP, written by clinicians and reviewed by former Notified Body assessors.
100% in-house clinical data management and EDC: eCRF design, DMP and DVP, powered by MILO Studio, natively built for EU MDR.
Structured post-market clinical follow-up meeting MDCG 2020-7 Level 4 criteria, with validated questionnaires and MILO Studio capture.
National registry integration (NJR, EUDAMED) for long-term real world evidence and PMCF follow-up of implantable devices.
Regulatory affairs and clinical strategy for CE mark pathways and equivalence, backed by a quality management system certified to ISO 13485.
A manufacturer running a multi-country device investigation faced rising monitoring costs and inconsistent site quality from a freelance CRA network. Eclevar rebuilt the approach around a risk-based monitoring plan written to ISO 14155: critical data and safety endpoints were defined up front, centralised review on MILO Studio flagged site anomalies in real time, and in-house CRAs concentrated on-site effort where the risk actually was.
Targeted source data verification replaced blanket 100% SDV, and every visit fed a clean, traceable trial master file. When the Notified Body reviewed the file, the monitoring trail was complete and defensible, and it directly supported the clinical evaluation report and ongoing PMCF.
Outcome: lower monitoring cost, consistent site quality and an inspection-ready evidence trail, instead of a scramble to reconcile data at close-out.
Former Notified Body reviewers from TÜV SÜD. We know what fails inspection and design programmes to avoid it.
Clinical ops, writing and data management. One point of accountability, no handoff fragmentation.
Proprietary EDC built natively for EU MDR, with Annex XIV mapping and AI eCRF generation.
Paris, London, Tokyo and Pune. In-house CRAs in seven countries, not a network of subcontractors.
Platinum Award winner, EUCROF 2026, ranked first for clinical innovation and data strategy.
ISO 13485 certified. Every programme structured for TMF completeness and Notified Body inspection readiness.
A network of employed CRAs and project leads, not subcontractors, gives sponsors consistent quality and one accountable team across the EU, the UK and Japan corridors.
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 high risk device programme.
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. »
Clinical trial monitoring is the independent oversight of a clinical investigation to protect participant safety and guarantee data integrity and protocol compliance. Under ISO 14155 and EU MDR 2017/745 it covers site initiation, interim monitoring visits, source data verification, consent and protocol compliance checks, and close-out, run on-site, remotely or through centralised risk-based methods.
Four main approaches: on-site monitoring, remote monitoring, centralised monitoring, and risk-based monitoring (RBM), which focuses on the critical data and processes that most affect safety and the primary endpoint. Most device programmes combine all four.
SDV is the CRA cross-check that data entered in the eCRF match the original source documents at the site. Under a risk-based approach, SDV is targeted at critical data points rather than applied 100% across every field, which is both ISO 14155 compliant and far more efficient.
Risk-based monitoring concentrates monitoring resources on the sites, data and processes carrying the highest risk to participant safety and to the reliability of the results. It combines centralised data review with targeted on-site and remote visits, and is explicitly encouraged for device investigations under ISO 14155.
On-site monitoring means a CRA physically visits the site to review source documents, device accountability and processes. Remote monitoring reviews the same evidence off-site via certified copies and the eCRF. A hybrid model plus centralised review gives the best balance of oversight, cost and site burden for most device trials.
Eclevar deploys in-house CRAs across seven countries, never subcontractors, working to a risk-based monitoring plan written to ISO 14155 from version 1. Monitoring runs on MILO Studio with real-time centralised review, targeted SDV and full trial master file traceability, structured for Notified Body inspection readiness.
Device monitoring must handle operator-dependent variables, device learning curves, implant follow-up and endpoints mapped to the General Safety and Performance Requirements, all under ISO 14155 rather than ICH-GCP. A specialist medical device CRO with former Notified Body reviewers designs the monitoring plan the way assessors expect to read it.
Talk to our specialists about your trial, your sites and a risk-based monitoring plan built to ISO 14155 from day one.
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