Under EU MDR your clinical evidence has to survive Notified Body scrutiny. The difference between a clean submission and a derailed one is decided by how you choose a CRO, not by who quotes lowest. We own delivery across European markets while you keep strategic control.
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. Independent recognition, externally judged, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders outsource their European trials to Eclevar. Read all client success stories.
Dr Mark DaCosta, COO and former TÜV SÜD reviewer, leads a team that reads a device trial the way a Notified Body will read it. When you outsource to Eclevar you get clinical and regulatory seniority on the file, not only operational staff, so an endpoint that will not satisfy the NB or a country that adds risk is flagged before you sign rather than mid-study. Monitoring is run by in-house CRAs, not subcontracted.
Outsourcing makes the most sense when a sponsor needs capability or capacity it cannot justify hiring for permanently. If the trial is occasional, spread across markets, or hinges on a high-stakes regulatory decision, an accountable partner is more efficient than a standing internal team. See our EU MDR regulatory strategy.
EU MDR and ISO 14155 knowledge you do not hold internally, with protocols built to standard from the first draft rather than corrected later.
Access to investigative sites across several European countries and regulatory routes without opening an office in each one.
Evidence that has to survive Notified Body scrutiny and support reimbursement, where a weak Clinical Evaluation Report can derail a submission.
A vendor runs the admin and hands the hard decisions back to you. An accountable partner owns delivery while you keep strategic control. These are the deliverables to demand.
A provider that subcontracts data management, biostatistics or monitoring introduces a handoff at every seam, and the seams are where accountability and timelines slip. We keep the core functions on one team.
Ask for named team members and their prior clearances, not a generic org chart introduced only after the contract is signed.
Is data management in house or subcontracted, and is the audit trail visible to you at any time?
Can the CRO shape evidence for the Notified Body and for reimbursement, or only collect it? Ask about the Clinical Evaluation Report and PMCF plan.
Watch for hidden hourly rates inside a project total, recruitment forecasts with no historical anchor, site fees marked "to be negotiated later", delivery teams introduced only after signing, and quiet subcontracting of core functions. Each change becomes a new round and each surprise surfaces mid-study. The test is simple: the most reliable signal of a good CRO is whether it can answer for the whole study when something goes wrong, and whether it will tell you the difficult truths before you sign.
Confirm where outsourcing adds value and where you keep control.
Build the protocol to EU MDR and ISO 14155 from the first draft.
Feasibility and multi-country submissions across ANSM, CPP, Italy and the MHRA.
In-house CRAs and in-house data management on MILO Studio.
CER and PMCF shaped for the Notified Body and reimbursement.
Beyond clinical operations we cover the full evidence chain, so you brief one accountable team instead of stitching local vendors together.
Regulatory affairs and ISO 13485 quality management aligned to your submission from day one.
Cardiology, orthopaedics, neuromodulation and wound care, with a dedicated cardiovascular clinical strategy for Class III devices.
In-house CRAs, MILO Studio data management and UK market access under one operational infrastructure.
Outsourcing makes the most sense when a sponsor needs capability or capacity it cannot justify building in house: EU MDR and ISO 14155 expertise it does not hold internally, access to sites across several countries, or high-stakes regulatory decisions where the clinical evidence has to survive Notified Body scrutiny. If the work is occasional or spread over many markets, an accountable partner is usually more efficient than a permanent internal team.
A vendor runs the admin and hands the hard decisions back to you. An accountable partner owns delivery while the sponsor keeps strategic control, and can answer for the whole study when something goes wrong. The most reliable signal of a good CRO is whether it will tell you early that an endpoint will not satisfy the Notified Body, that a country adds risk, or that a recruitment forecast is optimistic, before you sign rather than mid-study.
A provider that subcontracts data management, biostatistics or monitoring introduces a handoff at every seam, and the seams are where accountability and timelines slip. Eclevar keeps clinical data management in house on the MILO Studio platform, with a validated system and a complete audit trail, so data integrity and responsibility sit with one team.
Insist on line items priced by role and hour, site fees built in, and recruitment forecasts anchored to historical data. A project total alone hides the real comparison. Cheaper quotes often conceal quiet subcontracting, hidden hourly rates and site fees marked to be negotiated later, so each surprise surfaces mid-study.
Yes. Eclevar executes across multiple regulatory routes, including ANSM and CPP in France, the Italian Ministry of Health and the MHRA in the United Kingdom, with in-house CRAs so site initiation and monitoring are handled by our own team rather than outsourced. One accountable partner co-ordinates the whole study instead of stitching together local vendors.
Talk to our team about your device, your target markets and how to outsource without losing control of the evidence that reaches your Notified Body.
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