For Medtech teams that have already identified their target sites and are looking for a partner to manage regulatory and ethics submissions, hospital contracting, and essential documentation, in full compliance with EU MDR, UKCA, and local requirements.
La mise en place d'étude (Study Start-Up) concrétise votre essai clinique. Nous coordonnons les soumissions, les contrats, les budgets et les documents essentiels à travers les pays et les sites pour que les approbations restent alignées et que le recrutement puisse débuter sans délai.
A growing medical device company knew its target countries and sites but lacked the internal headcount and local knowledge to manage complex ethics submissions and hospital contract negotiations across Europe.
Site activation was progressive yet highly predictable. The sponsor avoided the need for large internal hiring, and the study launched exactly according to management's expectations.
An established manufacturer needed to quickly launch a PMCF study to meet EU MDR deadlines, but internal teams were overstretched. Local regulatory changes threatened to delay the submission.
Critical countries were activated precisely on time, generating PMCF data that fed directly into the Clinical Evaluation Report (CER) without missing a single regulatory milestone.
A strategic roadmap identifying target countries and sites, responsible parties, and activation dates to synchronize your clinical launch.
Creation of specialized dossiers including local ethics forms and regulatory checklists adapted to national standards.
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 center, exportable to your MILO EDC dashboard.
Final summary of validated sites, approved documents, and projected First Patient In (FPI) dates.
Review of your protocol, feasibility results, and target sites. Clarification of roles, timelines, and technical infrastructure.
Ensures total alignment on scope, preventing drift and keeping the start-up phase under strict regulatory control.
Final protocol or synopsis, Investigator’s Brochure (IB), device specifications, and selected country/site list.
Localization of Informed Consent Forms (ICF), preparation of country-specific dossiers, and adaptation of essential evidence to local Ethics Committee (EC) standards.
Parallel submissions to ECs and Competent Authorities. Management of query responses and leadership of contract and budget negotiations through to final signature.
Official green light for sites. Upload of essential documents into the TMF and project handover to the monitoring team for the start of recruitment.
It is the critical phase between protocol finalization and the activation of clinical sites. It includes managing submissions to Ethics Committees (EC) and Competent Authorities (CA), adapting Informed Consent Forms (ICF), negotiating hospital contracts and budgets, and collecting all essential documents to officially open recruitment.
As early as possible. Ideally, engage us right after site selection or during the final protocol drafting. This allows us to anticipate localization requirements and avoid "bottlenecks" during document collection.
Yes. We handle parallel submissions to national Competent Authorities (in accordance with EU MDR requirements) and local or central Ethics Committees across all participating countries in Europe and internationally.
Absolutely. We are fully flexible. We can work within your existing Electronic Trial Master File (eTMF) and use your specific contract and budget templates to maintain consistency with your internal standards.
While timelines depend on national regulatory contexts, our average KPI between contract signature and First Patient In (FPI) is under 14 weeks, thanks to parallel processing and our dedicated local CRAs.
We provide direct in-house coverage across Europe (EU and UK) and Latin America (LATAM). We also utilize strategic partnerships for seamless launches in Japan (PMDA) and India.
Book a strategy call with our clinical operations team to review your selected sites and accelerate your study start-up phase.
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