Clinical Trial Management

At a glance

Client

AXIOM International · Paragate Medical · INCLIVA · Hospital Clínico Universitario

Area

Clinical

Scope

Software Engineering, GCP-ICH, EDC/eCRF, Regulatory Compliance

Result

Multicenter cardiovascular trial under GCP-ICH & ISO 14155

What I did

Field Clinical Engineer contracted by AXIOM International for a multicenter cardiovascular clinical trial at INCLIVA – Hospital Clínico Universitario de Valencia. Responsible for in-hospital activation of the patient-connected device, calibration, troubleshooting, caregiver training, clinical data collection, regulatory documentation, and compliance with GCP-ICH and ISO 14155.

Technologies and topics

Related

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