The best eCRF systems are digital versions of the old paper forms. They improve data quality, allow real-time access, facilitate remote collaboration, and ensure that studies comply with regulations.
Milo eCRF is a fully customizable, intuitive Electronic Data Capture (EDC) solution, validated to ISO 14155:2020 standards.
It’s built for medical device manufacturers seeking to run compliant, efficient, and remotely monitored clinical trials.
Collect scientifically valid and MDR-compliant PMCF data using our platform:
Easy GDPR compliance.
Easily comply with GDPR requirements for informed consent and data protection. Our internal data protection officer monitors compliance for all studies.
Pre-validated and compliant data platform: Our platform meets the requirements of the ISO14155:2020 standard and GDPR.
Fully documented data traceability. All data entries automatically include user identification to ensure fully documented traceability from the source to the sponsor using advanced AI technology.
As the clinical evaluation report shows, claims of safety and clinical performance are not sufficiently supported by existing clinical evidence.
To keep the “Vascular Device” on the European market, the client must conduct a PMCF study to generate sufficient clinical data in accordance with “Chapter VI – Clinical Evaluation and Clinical Investigations, particularly Sections 62 to 82” and ISO 14155:2020.
Solution: Establishment of a European Vascular Registry
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