RT Clinica EDC for IVD Performance Studies

English- and Italian-language EDC/eCRF software for European IVD performance studies: versioned study design, protected capture, queries, SDV, e-signatures, audit trail, ODM/SDTM exports and inspection packages.

RT Clinica is an electronic data capture and eCRF platform designed around European IVD performance studies. It connects study setup, versioned forms, pseudonymised data capture, edit checks, queries, source-data verification, electronic signatures, database lock and export in one traceable workflow.

The platform includes technical controls designed to support regulated use, including database-enforced audit trails, study- and site-scoped access, server-side validation, content-bound signatures, EU hosting and controlled inspection exports. Study-specific PQ/UAT, procedures and sponsor approvals remain part of each customer deployment.

RT Clinica supports English and Italian interfaces, CDISC ODM 1.3 interchange, SDTM, Excel and CSV exports, and is available for product demonstrations and qualified customer deployments.