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Home

As a partner for IVD and CDx performance studies, we support IVD manufacturers and pharmaceutical companies with scientific precision and genuine partnership: robust studies, reliable analytics, and modular services.
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Clinical Study Supply Management

Kit assembly, worldwide shipping, temperature-controlled storage. We transport your samples and study materials safely – with individual, combined, and complete solutions.
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Contract Analytical Testing & Applications

We generate reliable data that secure your development and approval processes – even with small sample volumes and with no minimum order quantity.
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Sample Management

Your samples are valuable. We treat them accordingly: with seamless documentation, controlled pre-analytics, and global logistics.
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Study Management & Monitoring

We support you from planning to the Performance Study Report and safely navigate you through regulatory requirements.
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CRO Wiki

From IVDR and performance studies to ISO 13485: our CRO Wiki covers the most important terms, processes, and regulatory fundamentals of IVDs and CDx – grounded in expertise and presented in plain language.
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Biostatistics & Evidence

With TRIGA-S, you receive the statistical evidence your study needs: audit-proof, traceable, and guideline-compliant.
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Contact us

Get in touch with us – whether for a project enquiry, a question, or an initial introduction. We will get back to you within 48 hours.
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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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Pharma

From exploratory R&D analytics to submission-ready CDx validation: We support pharmaceutical companies with modular, IVDR-specialised services and dedicated points of contact.
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Diagnostics

From study planning through execution to submission-ready reports: TRIGA-S supports you with specialised expertise, a modular service portfolio, and a dedicated point of contact.
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Services

From planning to validation: TRIGA-S delivers IVDR-compliant studies – ISO 13485-certified, with an in-house BSL-2 laboratory and over 25 years of experience for reliable results.
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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.
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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.
A person wearing blue gloves and a white lab coat places a test tube into a rack, surrounded by other test tubes in a companion diagnostics laboratory setting.

Companion Diagnostics: requirements for CDx briefly explained

What are Companion Diagnostics (CDx)? Find out why they are a cornerstone of personalised medicine and what requirements they need to meet.
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Trial Master File briefly explained

What is the TMF (Trial Master File) and why is it crucial for studies? Find out why it is considered the “memory” of a study and which regulatory requirements it must meet.
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Sample storage briefly explained

Why is sample storage critical for sample integrity? Learn how stable temperature ranges, redundant systems, and continuous monitoring ensure reliable results.
A person holding a pen reviews and marks documents spread out on a desk, including papers with text, graphics, a QR code, and references to ISO 20916. The person's face is not visible.

ISO 20916 briefly explained

What does ISO 20916 require for IVD studies? Get an overview of the key requirements this international standard sets out for study organisation.
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Sample size calculation briefly explained

What is sample size calculation? Find out why getting sample size right is crucial for efficient resource allocation and reliable study results.
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EUDAMED briefly explained

What is behind the EU database for medical devices? A concise summary of modules, current status, and how to use it.
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DMIDS briefly explained

What is the DMIDS? Learn more about the BfArM’s platform for device and IVD registration, study submissions and regulatory data exchange.
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CRF briefly explained

How is study data collected and secured? Learn what constitutes a CRF (Case Report Form) and which requirements apply to validation and data protection.
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CRO briefly explained

What does a contract research organisation do? Learn more about the role and responsibilities of a CRO – especially for in vitro diagnostics (IVDs).
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Notified Bodies briefly explained

What are Notified Bodies? Learn about their role and responsibilities in the EU market access process for medical devices and IVDs.
A scientist in a contract laboratory, wearing a lab coat, gloves, and safety glasses, looks through a microscope in a laboratory filled with equipment and bottles on the table.

Contract laboratory briefly explained

What is a contract laboratory and what does it do? Find out when and why working with a contract laboratory adds value for scientific analyses and measurements.