For Medtech teams that already know their target sites and need a partner to manage ethics and regulatory submissions, site contracts, and essential documents in line with EU MDR, UKCA, and local requirements.
Study start-up moves your trial into reality. We coordinate submissions, contracts, budgets, and essential documents across countries and sites so approvals stay aligned and recruitment can begin without delay.
A growing device company knew which countries and centers they wanted to use but lacked the internal headcount and local knowledge to handle ethics submissions and complex contract negotiations across Europe.
Sites opened in a phased but highly predictable way. The sponsor avoided hiring a large internal team and the study was ready to recruit perfectly in line with board expectations.
An established manufacturer needed to launch a PMCF study quickly to support MDR timelines, but internal staff were tied up. Local regulatory changes in key European countries threatened to derail the submission.
Critical countries went live precisely on time, generating PMCF data that fed directly into the Clinical Evaluation Report (CER) and PMCF report without missing a single EU MDR milestone.
A strategic roadmap identifying countries and sites in scope, owners, and target activation dates to synchronize your clinical launch.
Country-specific dossiers including local ethics forms, localized regulatory checklists, and regulatory requirements mapped to local 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 every center, fully exportable to your MILO EDC dashboard.
Final summary of green-lit sites, validated documents, and projected First Patient In (FPI) dates for the recruitment phase.
We review your protocol, feasibility outputs, and target sites. We clarify roles, timelines, and technical infrastructure (Sponsor vs. Eclevar systems).
Ensures total alignment on scope, preventing "scope creep" and keeping the start-up phase under tight regulatory control.
Final protocol or synopsis, Investigator's Brochure (IB), device specifications, and selected countries/sites list.
We localize Informed Consent Forms (ICFs), prepare country-specific dossiers, and adapt essential evidence to meet local Ethics Committee (EC) standards.
Parallel submissions to ECs and Competent Authorities. We manage query responses and lead site contract/budget negotiations to final signature.
Official green-light for sites. Essential documents are uploaded to the TMF, and the project is handed over to the monitoring team for enrollment.
It is the critical phase between protocol finalization and site activation. It involves managing Ethics Committee (EC) and Competent Authority (CA) submissions, adapting informed consents, negotiating site contracts and budgets, and collecting all essential documents to officially open the site for enrollment.
As early as possible. Ideally, engage us right after site selection or while the final protocol is being drafted. This allows us to proactively prepare localization requirements and prevent "bottleneck" delays in document collection.
Yes. We handle parallel submissions to national Competent Authorities (in line with EU MDR requirements) and local or central Ethics Committees across all participating countries in Europe and beyond.
Absolutely. We are fully flexible. We can work within your existing Trial Master File (eTMF) and CTMS, and utilize your corporate templates for contracts and budgets to maintain consistency with your internal standards.
While timelines depend on specific country regulatory landscapes, our average benchmark from signed agreement to First Patient In (FPI) is under 14 weeks, achieved through parallel processing and dedicated local CRAs.
We provide direct in-house coverage across Europe (EU and UK) and LATAM. We also utilize strategic partnerships for seamless start-up in Japan (PMDA) and India.
Feasibility identifies the right sites. Start-up secures the legal and ethical green light to open them. Monitoring (following start-up) ensures the data collected at those sites is accurate once enrollment begins.
Book a strategy call with our clinical operations team to review your selected sites and accelerate your study start-up phase.
