Our services include:
-
Analytical Performance Studies
-
Clinical Performance Studies
-
Layman Usability Studies
-
Post-Market Studies
-
Sample Collection Studies
-
Companion Diagnostics Studies
-
Feasibility Studies
-
Exploratory Studies
Performance Studies according to IVDR/CFR
Our cross-functional and GCP/GCLP-qualified teams develop tailor-made solutions to ensure the success of your analytical and clinical performance studies for market approval. As your reliable partner, we guarantee the correctness, completeness, traceability, and validity of the data, and we document in accordance with applicable standards and regulations.
Sample Collection Studies
We plan and conduct prospective and retrospective sample collection studies of biological samples according to national laws, as needed by investigators, to support development and method validation. Our comprehensive services include full study documentation, site management, ethics clearance, clinical trial supply, and logistics
Exploratory & Feasibility Studies
TRIGA-S offers services to support the development of in vitro diagnostics, including biomarker testing and validation, from pre-clinical development to proof of concept.
