For MedTech teams that have already run feasibility and need a partner to drive ethics and regulatory submissions, hospital contracting and essential documents to First Patient In, in full compliance with EU MDR, UKCA and local requirements.
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 study start-up and site activation across Europe. Read all client success stories.
Ethics Committee and Competent Authority submissions fail on avoidable, country-specific details. Dr Mark DaCosta, COO and former TÜV SÜD reviewer, makes sure every dossier is built to the local standard first time, so queries are minimised and your sites reach First Patient In on schedule.
A complete, tracked start-up package that takes each centre from selection to activation without handoff friction. You receive:
A roadmap identifying target countries and sites, responsible parties and activation dates to synchronise your clinical launch.
Specialised dossiers with local ethics forms and regulatory checklists adapted to each national standard.
Verified copies of applications, supporting evidence and approval letters, filed in real time within your TMF or our managed environment.
Dynamic monitoring of contract status, budget terms and signatures for each centre, exportable to your MILO EDC dashboard.
A final summary of validated sites, approved documents and projected First Patient In dates, handed to the monitoring team.
A growing device company knew its target sites but lacked the headcount and local knowledge to manage ethics submissions and hospital contracts across Europe.
Outcome: progressive, highly predictable activation with no large internal hiring, launched exactly to plan.An established manufacturer had to launch a PMCF study fast to meet MDR deadlines while internal teams were overstretched.
Outcome: critical countries activated exactly on time, feeding PMCF data straight into the CER without a missed milestone.A US-based company entered the EU with limited knowledge of European ethics and hospital contracting processes.
Outcome: a three-country activation with predictable timelines that met Ethics and Competent Authority 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 feasibility and site selection 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. »
Study start-up is the phase between site selection and First Patient In: ethics and Competent Authority submissions, hospital contract and budget negotiation, essential document collection and TMF set-up, and formal site activation for your clinical investigation.
As soon as your target sites are identified, ideally right after feasibility. Early involvement lets us sequence submissions and contracting in parallel and protect your First Patient In date.
Yes. We handle Ethics Committee and Competent Authority submissions in parallel, manage query responses, and lead hospital contract and budget negotiation through to final signature.
Yes. The team is platform agnostic and can work within your existing TMF, templates and validated systems, or provide a managed MILO environment if you prefer.
Our average time between contract signature and First Patient In is under 14 weeks, depending on country mix and ethics timelines, tracked against the start-up plan from week one.
Europe (EU & UK) is our core, with in-house CRAs in France, Germany, Italy and Spain, plus corridors to Japan (PMDA) and India (CDSCO).
Book a consultation and we will review your selected sites and country mix, then map the submissions, contracting and documents needed to reach First Patient In on time.
Book a consultation