Eclevar's registry design methodology is built on decades of expertise from former notified body and competent authority leadership. We apply rigorous scientific principles and regulatory best practices to ensure your registry generates high-quality, regulatory-acceptable real-world evidence.
We conduct comprehensive feasibility assessments, define clear objectives aligned with MDR requirements, establish inclusion/exclusion criteria, and design standardized data collection protocols that minimize bias.
We identify and recruit high-performing clinical sites, conduct comprehensive investigator training on protocol requirements, data quality standards, and regulatory compliance to ensure consistent execution across all centers.
We implement robust electronic data capture systems (eCRF), establish standardized case report forms, monitor data quality in real-time, and ensure compliance with GDPR, ICH-GCP, and 21 CFR Part 11 requirements.
We conduct regular source data verification, implement continuous quality checks, perform site audits, and maintain rigorous oversight to ensure data integrity and protocol adherence throughout the registry lifecycle.
We conduct comprehensive statistical analysis, prepare detailed registry reports, support notified body interactions, and ensure all deliverables meet MDR Annex XIV Part B requirements for regulatory acceptability.
Our team combines deep regulatory expertise with proven operational excellence in managing complex, multi-center registries under EU MDR. We bring a unique perspective from our leadership's background in notified bodies and competent authorities.
Former notified body and competent authority leadership with direct involvement in MDCG guidance development and MDR implementation across Europe.
Rigorous methodology grounded in ISO 14155:2020, ICH-GCP principles, and best practices for real-world evidence generation and statistical analysis.
Established relationships with clinical sites, hospitals, and research centers across France, UK, Germany, and EU member states for rapid site recruitment and execution.
Access to Milo Healthcare's proprietary EDC platform with advanced features for real-time monitoring, data validation, and regulatory compliance tracking.
Successfully managed 165+ clinical trials and registries for medical device companies, supporting MDR submissions and regulatory approvals across therapeutic areas.
End-to-end registry management from design through regulatory submission, including medical writing, statistical analysis, and notified body coordination.
A comprehensive example of how Eclevar designed and executed a high-quality registry for a vascular device manufacturer, overcoming key challenges through innovative data linkage strategies.
A vascular device manufacturer needed to confirm the safety and performance of their devices across multiple anatomical locations (carotid artery and femoral) under EU MDR requirements. Existing clinical evidence was insufficient to support continued market authorization.
Duration: 3-year patient follow-up with ongoing data collection and analysis
Outcome: By linking registry data to the French national health insurance claims database (SNDS), we dramatically improved data completeness and minimized follow-up loss from 39% to just 1% over 5 years. This innovative approach filled critical data gaps, enhanced statistical power, and generated regulatory-acceptable evidence that supported MDR CE mark certification and established a foundation for long-term European vascular device registry.
Every registry is designed with MDR compliance as the foundation, ensuring your evidence meets notified body expectations and regulatory requirements from day one.
Rigorous quality assurance, real-time monitoring, and continuous audits ensure your registry data is complete, accurate, and defensible in regulatory submissions.
Proven processes for site recruitment, investigator training, protocol adherence, and patient retention minimize delays and maximize data quality throughout registry execution.
Access to advanced EDC technology, database linkage strategies, and real-world evidence methodologies that enhance registry power and regulatory acceptability.
Assigned registry manager, regular communication, and proactive problem-solving ensure your project stays on track and exceeds expectations.
Track record of successful registries across therapeutic areas, with evidence supporting MDR approvals, notified body assessments, and long-term device surveillance.
Let's discuss how Eclevar can design and manage a registry that generates regulatory-acceptable real-world evidence and supports your MDR compliance strategy.
