Strong clinical evidence depends on clean, well-organised data. Our experts design device-specific ecosystems that align your database with regulatory requirements.
Custom design tailored to MedTech workflows and MDR/IVDR requirements.
Rigorous management in your EDC or through the Milo Health platform.
Early involvement to ensure analysis plans and endpoints align perfectly.
Seamless transition from clinical study reports to notified body submissions.
At ECLEVAR MEDTECH, we recognize that high-quality clinical evidence is the foundation of EU MDR compliance and successful reimbursement. Unlike many CROs that outsource critical data functions, we operate a fully in-house department.
Ensuring data is clean and robust through close collaboration between departments.
Systems built to withstand the most aggressive Notified Body and HTA audits.
Data management specifically designed to meet medical device regulatory standards.
Our Biometrics department is led by Sébastien Meier Piantanida, an industry veteran with 30 years of experience in Clinical Data Management and systems governance. Having held senior leadership roles in top biotech companies, he ensures that every project at Eclevar is executed with pharmaceutical-grade discipline.
We provide a seamless flow of data from the clinical site to the final clinical evaluation report. By keeping these services in-house, we maintain direct control over data quality and timelines.
Utilizing our proprietary MILO platform, we build study-specific databases tailored for medical device clinical investigations and PMCF registries.
Our in-house workflows for query management and rigorous data cleaning ensure high-integrity datasets from the outset.
We specialize in maintaining patient retention and data completeness over long-term programs, which can extend up to five years.
We prepare submission-ready datasets that meet the strict format and traceability expectations of global regulatory bodies.
Our statisticians ensure that your clinical endpoints are both meaningful and defensible under the strictest regulatory reviews.
Expert power determination to satisfy Notified Body scrutiny for Class IIb and Class III devices.
Developing robust strategies for handling missing data and complex technology endpoints.
Reports tailored for CER updates, DSMB reviews, and HTA dossiers.
Applying specialized methods to translate routine clinical use into credible performance claims.
