Your Partner for IVD and CDx Performance Studies
TRIGA-S – Empowering Healthcare Together
Studies. Services. Solutions. As a specialised Contract Research Organisation (CRO), we support in vitro diagnostic (IVD) manufacturers in conformity assessment under the IVDR and pharmaceutical companies from R&D analytics through to companion diagnostics (CDx) validation.
We deliver robust evidence for your market access, and keep your IVDR conformity and CDx milestones on track.
TRIGA-S in Numbers
Study Projects Delivered
Study Sites Managed
Samples Managed
Where We Conducted Studies
The Foundation for Your Study
In-House BSL-2 Laboratory
Years of IVD Expertise
ISO 13485 Certified & GCP/GCLP Compliant
Genuine Partnership
Modular Services
IVDR-Compliant Performance Studies – End to End
Facing ambitious timelines, limited sample availability, or uncertainty around specific IVDR requirements? From study planning and sample management to biostatistics and audit-ready study reports, ready for inclusion in your technical documentation, we guide you through the entire process.
CDx Studies & Services Aligned with Your Drug Development Timeline
Your CDx milestones must keep pace with your drug development timeline. We know IVD regulations, understand pharmaceutical requirements, and support you from exploratory R&D analytics through to CDx validation – efficiently and with full audit readiness.
Modular, Audit-Ready, and Tailored to Your Needs
Our Services at a Glance
From study management and sample management to biostatistics, contract analytical testing, and clinical study supply, through to regulatory support – as a specialised CRO, we take analytical and clinical performance studies from planning to submission-ready reports.
All our IVD and CDx services can be booked individually, in combination, or as a complete solution.
"Ambitious timelines. Limited resources. Restricted sample availability. These are the moments that define a real partnership. We listen, think ahead, and plan proactively – drawing on decades of experience. That is how we shape the future of diagnostics – Empowering Healthcare Together."
– Dr. Andreas Franke, Managing Director / COO
Successful Together:
A Selection of Our Clients
Get in Touch
Would you like to discuss a specific project, ask a question, or find out more about our services? Give us a brief outline of what it’s about – we will get back to you within 48 hours.
Email Address
Phone Number
Address
TRIGA-S GmbH
Mühltal 5, 82392 Habach, Germany
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Book a meeting with us and let’s talk about your project. We look forward to getting to know you.
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Abbreviations
BSL-2 Laboratory: Contract laboratory operating at Biosafety Level 2 (BSL-2)
CDx: Companion Diagnostics
CRO: Contract Research Organisation
GCP: Good Clinical Practice
GCLP: Good Clinical Laboratory Practice
ISO: International Organization for Standardization
IVD: In vitro diagnostics
IVDR: In Vitro Diagnostic Regulation
R&D: Research & Development

