Study to Analyze the Clinical Performance of an IVD Product

Efficient data collection, monitoring and validation of a clinical trial with the help of eCRF (electronic Case Report Form) up to the successful completion of the study

Study to Analyze the Clinical Performance of an IVD Product

TRIGA-S is a CRO specializing in clinical and analytical performance studies for in vitro diagnostics (IVD). In 2022, TRIGA-S started a clinical performance study of a SARS-CoV2 in vitro diagnostic agent on behalf of an IVD manufacturer in accordance with the In Vitro Diagnostics Regulation (IVDR). Climedo provided support in the area of data management with its eCRF system (electronic Case Report Form System). In doing so, the Clinical Research Associates (CRAs) in the study benefited from real-time data access, efficient data monitoring and improved collaboration.

TRIGA-S

Client

In Vitro Diagnostics (IVD)

Study area

431

Subjects

8 months

Study duration

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