01 / CLINICAL RESEARCH
EDC platform
Drox Health Science · 2023 — Present
Clinical data capture, operational workflows and cloud infrastructure.
Context
An Electronic Data Capture platform for collecting and managing clinical study information, with requirements for permissions, validation and traceability.
My contribution
Development of Vue.js interfaces, forms, administrative modules and visit workflows; integration with .NET APIs and direct collaboration with operational users. AWS infrastructure and CI/CD pipelines.
Documented work
Implementation of electronic signatures, audit controls and traceability. Leadership of the technical and documentation process that enabled the platform to obtain external certification for compliance with US FDA 21 CFR Part 11 Electronic Records.