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.
Monitoring ensures your study stays compliant, your data remains reliable, and issues are addressed early. Our Clinical Research Associates combine on-site and remote review to confirm protocol adherence, verify critical data, and give you clear visibility of study progress from First Patient In to database lock.
A sponsor planned a multi-country trial but only had one internal Clinical Research Associate. They were worried about keeping oversight of several high-enrolling sites and avoiding inspection findings.
The study stayed perfectly on track with a harmonized, risk-based monitoring plan and a clear audit trail that stood up to strict internal and external review.
An established manufacturer needed to monitor a PMCF study collecting data during routine care. They wanted to minimize site burden while still fully meeting strict EU MDR expectations.
Sites felt supported rather than overloaded. The sponsor successfully demonstrated to Notified Bodies that their PMCF real-world data was actively and rigorously monitored.
A sponsor based outside Europe had limited knowledge of EU GCP and ISO 14155 expectations for device monitoring. They required local experts to ensure the study would pass inspection.
Local EU Clinical Research Associates were deployed. Findings reduced over time, there were zero critical findings during external inspection, and the sponsor gained confidence for future European studies.
A comprehensive document establishing the risk-based monitoring strategy, identifying critical data points, detailing the balance of on-site versus remote review, and scheduling planned visit frequencies for each site.
Structured reports documenting informed consent, subject eligibility, device accountability, protocol adherence, Source Data Verification (SDV), identified issues, and corrective actions. All reports are filed securely within the Trial Master File (TMF).
Detailed listings and analytical notes derived from Electronic Data Capture (EDC) reviews. This process highlights missing data, statistical outliers, protocol deviations, and site-specific performance trends alongside actionable recommendations.
A live tracking system integrated within the MILO EDC, recording all protocol deviations, root cause analyses, corrective actions, and preventive actions. It provides real-time status visibility segmented by clinical site.
A final, comprehensive summary detailing all monitoring activities, resolution of open actions, and overall site performance metrics. This documentation supports strict inspection readiness and feeds directly into the Clinical Study Report (CSR) and Clinical Evaluation Report (CER).
We analyze your clinical protocol, device risk profile, primary endpoints, and data architecture. We author a Risk-Based Monitoring Plan (RBMP) that balances intensive oversight where critical and optimized remote review where appropriate.
Monitoring efforts are concentrated on variables that directly impact patient safety and data integrity. You avoid unnecessary site visits while rigorously satisfying ISO 14155, EU MDR, and UKCA regulatory expectations.
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.
Our localized Clinical Research Associates (CRAs) implement the RBMP through scheduled Interim Monitoring Visits (IMVs) and continuous remote data analytics, ensuring immediate resolution of data queries and protocol deviations.
We conduct comprehensive Close-Out Visits (COVs), verify the resolution of all outstanding queries, finalize the Trial Master File (TMF), and deliver a fully validated, inspection-ready dataset for Database Lock.
