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eCRF (Electronic Case Report Forms)

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.

eCRF

The Next-Generation EDC Platform for Medical Devices

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.

Design & Customization

  • No-code CRF Builder: Drag-and-drop form creation with no coding required
  • Pre-validated templates: For PMCF, RWE, pre-market studies, and more
  • Conditional logic: Dynamic fields based on prior responses
  • Automated quality checks: Real-time data entry validation

Operations & Monitoring

  • Integrated eMonitoring: Real-time query tracking and resolution
  • Activity dashboard: Consolidated view of sites, patients, and statuses
  • Protocol deviation and violation management
  • Complete audit trail: Full traceability by user action

Security & Compliance

  • Compliant with GDPR, 21 CFR Part 11 & ISO 27001
  • HDS hosting in France / EU
  • Strong authentication & role-based access control
  • Version-controlled CRF history

Interoperability & Integrations

  • Connects with Milo eCOA (patient self-assessment questionnaires)
  • Integrates with Milo Registry (longitudinal databases)
  • FHIR & HL7 compatible: Connects with EMRs/hospitals
  • Exports to eTMF and CER-ready formats
eCRF

Results with Milo eCRF

0 %
CRF completion rate
0 % Faster
Data cleaned
0 %
Simplified CER export in structured format

Advantages of using an electronic data capture system in 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.

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Unmatched expertise to conduct your trials with assured quality and to provide patients with safe and innovative therapies.

Register with the French health data center.

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.

Objectives

  1. Confirm the safety and performance of the vascular device throughout its intended lifespan at two anatomical sites: carotid and femoral.
  2. Identify and analyze emerging risks based on factual evidence.
  3. Ensure continued acceptance of the benefit-risk ratio according to the EU-MDR.
  4. Identify any potential systematic misuse or off-label use of product X to verify that the intended use is correct.

Methodology

  • A sponsor conducted a multicenter RWE study to collect clinical data on the vascular device. The aim was to examine short- and long-term outcomes of device use when exposed to a broader and more diverse population.
  • 300 subjects were evaluated from 3 different sites, with 150 subjects assessed in the carotid position and at least 150 in the femoral position.

Benefits

  1. Contributes to a broader body of developing evidence.
  2. Representative population.
  3. Accepted by the notified body for the MDR certificate.
  4. Limitation: Incomplete long-term evidence.

Solution: Establishment of a European Vascular Registry

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eCRF