TRIGA-S GmbH
Studies. Services. Solutions. TRIGA-S GmbH is a specialised Contract Research Organisation (CRO) with over 25 years of experience in analytical and clinical performance studies for in vitro diagnostics (IVDs) and companion diagnostics (CDx).
As an ISO 13485-certified CRO with our own in-house BSL-2 contract laboratory, we support IVD manufacturers with conformity assessment under the IVDR – and pharmaceutical companies from exploratory R&D analytics through to CDx validation. We deliver compliant and audit-ready results for your regulatory success – so you can face audits with confidence and achieve fast, secure market entry.
Our Highlights
- In-house BSL-2 contract laboratory – for safe and precise analytics
- 25+ years of IVD expertise
- ISO 13485-certified, GCP/GCLP-compliant
- European and international logistics with full chain-of-custody traceability
- Modular portfolio – individual services, combinations, or end-to-end solutions
- Flexible & adaptable – fast project setup, last-minute changes, no minimum quantities – also as a Functional Service Provider (FSP)
Our Services
Study Management & Monitoring
From study preparation, site management, monitoring, and data management – including eCRF design and maintenance – to the audit-ready final report, TRIGA-S manages your IVD study in accordance with the IVDR, ISO 20916, and, if applicable, CFR, to ensure full traceability and a submission-ready outcome.
Biostatistics & Evidence
Guideline-compliant analysis plans (SAP), conservative sample size planning, and validated analysis reports (SAR) that stand up to audits and regulatory authorities. Including Post-Market Performance Follow-up (PMPF).
Sample Management
A validated process for the entire sample lifecycle – from receipt, storage, aliquoting, and processing through to labelling and global shipping. Full chain-of-custody documentation, audit-ready.
Contract Analytical Testing & Applications
From exploratory contract testing and feasibility studies to method comparisons and application works – precise, comparable, and submission-ready, even with the smallest sample volumes.
In-house BSL-2 laboratory: clinical chemistry assays, immunoassays, ELISAs, and real-time PCR.
Clinical Study Supply Management
Worldwide coordination of study logistics: from the assembly of validated collection kits and temperature-controlled storage to global shipping – regulatory and customs-compliant, with full chain-of-custody traceability.
All services can be booked individually, in combination, or as a complete end-to-end solution.