Empowering Healthcare Together
Your Partner for IVD and CDx Performance Studies in Europe
For over 25 years, we have supported in vitro diagnostics manufacturers and pharmaceutical companies with scientific precision and genuine partnership.
As an ISO 13485-certified CRO with our own BSL-2 laboratory, we develop customized solutions – modular, flexible and tailored to your needs: from sample analysis to clinical validation.
We Transform Potential into Measurable Progress
“Curiosity is my driving force – and the reason I founded TRIGA-S. To me, curiosity means listening before concluding, questioning before deciding, and understanding deeply before proposing a solution. This is how we turn potential into measurable progress – because in in vitro diagnostics, where evidence determines market access and patients depend on the outcome, good intentions aren’t enough. Our clients need a partner who gets it right. That’s what we’re here for.”
– Sabine Radiske, Managing Director & Founder
Together Towards Measurably Better Health
Our team combines scientific excellence with personal reliability. We work hand in hand every day towards our common goal: to measurably improve diagnostics and therapy. This attitude not only shapes our internal collaboration, but also our dealings with customers, partner organizations and patients – for study results that everyone can rely on.
What Our Clients Say
“As experts in molecular in vitro diagnostics and products for medical research, we at TIB MOLBIOL stand for the highest reliability and clinical significance of our IVD tests. The high-quality and efficient execution of clinical and analytical performance studies is particularly important to us.
Together with TRIGA-S, we were able to implement our studies in a targeted and regulatory compliant manner and obtained high-quality results. We look forward to working with them again at any time.”
– Markus Berg
Project Leader | Chief of Staff, TIB Molbiol Syntheselabor GmbH
“We were facing a bottleneck in site identification for one of our IVD projects and engaged TRIGA-S. The team quickly developed a pragmatic solution. Structured and professional, but without unnecessary bureaucracy.
The collaboration was uncomplicated and goal-oriented, which is why we would rely on TRIGA-S’s expertise again at any time for future IVD projects.”
– Dr. rer. nat. Katja Waterstradt
Research & Development, MedInnovation GmbH
Quality That Builds Confidence
ISO 13485-Certified
Verified quality, traceable processes, and the assurance that studies comply with regulatory requirements from planning through to the final report: Our quality management system is ISO 13485 certified and is regularly audited by independent bodies.
We Work According to International Standards
ISO 9001 – Quality Management
We rely on structured processes and continuous improvement in all areas.
ISO 20916 – Clinical Performance Studies for IVD
We plan, conduct and evaluate in vitro diagnostic studies according to standardized procedures.
GCP / GCLP / GDP
Good Clinical Practice, Good Clinical Laboratory Practice, Good Distribution Practice – We work to the highest standards in clinical research, laboratory work and logistics.
Are you planning an IVD or CDx performance study? Let's talk about your requirements – free of charge and with no strings attached.
Milestones in the TRIGA-S Success Story
Milestones in the TRIGA-S success story
Our vision for sustainability
Together, We Create a Better Future – for People and Our Planet.
As a CRO for IVD and CDx performance studies, we proactively assume responsibility beyond the studies themselves – for patients, our clients, our employees, and future generations. With our sustainability report, we transparently show where TRIGA-S stands today, what goals we have set for ourselves, and how we are improving step by step.
Our Sustainability Report 2024 marks the start of our reporting – aligned with the CSRD (Corporate Sustainability Reporting Directive) and prepared on the basis of the VSME (Voluntary Standard for Medium Enterprises):
Environment – own photovoltaic system, laboratory waste water treatment, waste separation, recycling, own autoclaving process
Social – remuneration based on collective agreements, company health insurance, flexible working time models, bike leasing, training and further education, regional donations
Governance – proactive sustainability reporting, quality management, digitalization
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Abbreviations
BVMA: Federal Association of Medical Contracting Organizations
CDx: Companion Diagnostics
CRO: Contract Research Organization
CSRD: Corporate Sustainability Reporting Directive
EU: European Union
GCP: Good Clinical Practice
GCLP: Good Clinical Laboratory Practice
GDP: Good Distribution Practice
GxP: Good Practices
ISO: International Organization for Standardization
IVD: In vitro diagnostics
IVDR: In Vitro Diagnostic Regulation
BSL-2 Laboratory: Contract laboratory operating at Biosafety Level 2 (BSL-2)
VSME: Voluntary Standard for Medium Enterprises