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

> 500

Study Projects Delivered

120+

Study Sites Managed

> 2.5 million

Samples Managed

18+ Countries

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

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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.

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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

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Our Memberships

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.

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TRIGA-S GmbH
Mühltal 5, 82392 Habach, Germany

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Speak With Us – No Obligation, No Charge

Book a meeting with us and let’s talk about your project. We look forward to getting to know you.

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About Us

We have been combining scientific precision with genuine partnership since 1998. Find out more about our work, our history and what sets us apart as a CRO.
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Careers

More than a job: a meaningful role in a team that sticks together. Shape your professional future with us!
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News & Insights

Latest updates from the IVD-industry and TRIGA‑S: news, events, and in-depth expertise on studies, regulatory requirements, and performance evaluation.

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