For Medtech teams who need consistent on-site and remote oversight that meets ISO 14155, EU MDR, and UKCA expectations without overwhelming investigators and site staff. Eclevar ensures absolute data integrity from First Patient In to database lock.
We analyze your clinical protocol, device risk profile, and primary endpoints to author a Risk-Based Monitoring Plan (RBMP). This focuses oversight on variables that directly impact patient safety and data integrity while rigorously satisfying ISO 14155 and EU MDR expectations.
Navigating site readiness is critical. We execute Site Initiation Visits (SIVs), train principal investigators on strict protocol adherence, verify comprehensive EDC proficiency, and establish robust Source Document Verification (SDV) procedures before first patient activation.
Uncompromising oversight driven by our localized CRA teams. We implement scheduled Interim Monitoring Visits (IMVs) and continuous remote data analytics via MILO EDC to ensure immediate resolution of data queries and protocol deviations before they impact study validity.
Data integrity is governed by a live tracking system. We conduct detailed EDC reviews to highlight missing data or statistical outliers, while managing a real-time Deviation & CAPA tracker to record root cause analyses and corrective actions across all sites.
Flawless database lock protocols. We conduct comprehensive Close-Out Visits (COVs), verify the resolution of all outstanding actions, and finalize the Study Master File (TMF) to deliver a fully validated, inspection-ready dataset for your CSR and CER.
Nancy Boodhun is the operational force driving Eclevar Medtech's clinical excellence. As Head of Clinical Operations, she specializes in translating the rigorous requirements of EU MDR and ISO 14155:2020 into flawlessly executed site-level strategies.
Supported by Lead Clinical Project Manager Charline Petitdemange, Nancy oversees the entire monitoring lifecycle—from site qualification and investigator training to the absolute maintenance of the Trial Master File (TMF). Her team ensures that every patient safety event is captured and every data point is verified, providing sponsors with an inspection-ready dataset that withstands any Notified Body scrutiny.
Consult with our clinical operations experts to map out a site oversight and monitoring strategy that guarantees **ISO 14155 compliance** and **Notified Body readiness**.
