Evidence That Unlocks Markets
TRIGA-S Services
We support IVD manufacturers with conformity assessment under the IVDR. For pharmaceutical companies, we support CDx validation in close alignment with their drug development timelines.
As an ISO 13485-certified CRO with our own in-house BSL-2 contract laboratory, we deliver compliant and audit-ready results for your regulatory success – so you can face audits with confidence and achieve fast, secure market entry.
Modular CRO Services for Your Success
Every project is unique. That is why our service portfolio is modular. You can book all our services individually, combined, or as a complete solution.
Quality and Expertise That Move You Forward
In-House BSL-2 Contract Laboratory
Years of IVD Expertise
ISO 13485-Certified Quality
Global Logistics
Maximum Flexibility
IVDR-Compliant Performance Studies – End to End
From study planning and sample management to audit-ready documentation, we ensure that IVD manufacturers receive robust performance data for their conformity assessment.
CDx Studies and R&D Analytics Aligned with Your Drug Development Timeline
Companion Diagnostics (CDx) require a partner who knows IVD regulations and understands pharmaceutical requirements. We support you as a specialised CRO partner from exploratory R&D analytics through to CDx validation.
Modular, Audit-ready, and Tailored to Your Needs
Our Services at a Glance
From Planning to Final Report
Study Management & Monitoring
From study preparation, site management, monitoring, and data management – including eCRF design, programming, and maintenance – to the audit-ready final report, TRIGA-S manages your IVD study under the IVDR, ISO 20916, and, if applicable, CFR, to ensure full traceability and a submission-ready outcome.
Your Advantages With TRIGA-S
- Gain regulatory confidence through complete and traceable documentation.
- Launch faster with short setup phases and structured processes that prevent rework and delays.
- Maintain full visibility into recruitment and data quality with real-time dashboards.
- Benefit from validated EDC/eCRF solutions: efficient query management, audit trails, and consistent data flows between monitoring and data management.
- Accelerate your market launch with strategic guidance and robust risk assessment tailored to your IVD study.
Audit-ready analysis plans and reproducible results
Biostatistics & Evidence
A study provides data, but only the correct analysis delivers robust evidence. TRIGA-S links your product goals with relevant regulatory requirements and international standards (e.g. IVDR, CFR, relevant CLSI guidelines, ISO 20916) – with guideline-compliant analysis plans (SAP), conservative sample size planning, and validated analysis reports (SAR) that stand up to scrutiny in audits and before regulatory authorities.
Your Advantages With TRIGA-S
- Obtain submission-ready results with guideline-compliant analysis plans (SAP) and validated analysis reports (SAR).
- Minimise study risks through careful study design, solid sample size, clear acceptance criteria, and the selection of optimal methods.
- Make informed decisions quickly and with confidence, backed by clear, transparent, and meaningful presentation of study data.
- Maintain oversight after your market launch with analyses for Post-Market Performance Follow-up (PMPF).
Integrity, Traceability, Processing & Panels
Sample Management
The quality of study data is often determined before the actual analysis begins. With TRIGA-S, you get sample management designed to do exactly that: a validated process that seamlessly controls and documents the entire sample lifecycle – from receipt, storage, aliquoting, and processing through to labelling and global shipping.
Your Advantages With TRIGA-S
- Rely on full chain-of-custody traceability: Each sample is assigned a unique identifier upon receipt and documented in a fully audit-ready manner.
- Count on secure storage under defined conditions, with temperature control backed by redundant systems.
- Receive customised panels, aliquots, and control materials for your platforms and study requirements.
- Stay flexible even with small volumes and last-minute project changes.
- Trust in seamless processes – one point of contact for sample collection, storage, processing, and shipping, with no gaps at the handover.
Reliable Data for Your Research
Contract Analytical Testing & Applications
A test must not only perform in the development environment – it must also prove itself in daily clinical practice. From exploratory contract testing and feasibility studies to method comparisons and application work, TRIGA-S provides the data-driven foundation for your strategic decisions – precise, comparable, and submission-ready, even with the smallest sample volumes.
Your Advantages With TRIGA-S
- Obtain reliable results even with small volumes and without minimum quantity requirements.
- Test your biomarker hypotheses early with exploratory studies and feasibility analyses.
- Count on validated methods and audit-ready reports, backed by our in-house BSL-2 laboratory and ISO 13485 certification.
- Make confident decisions based on clear method comparisons and application work.
Reliable Material Availability
Clinical Study Supply Management
Well-planned logistics keep your study reliably on track. From the assembly of validated collection kits and temperature-controlled storage to global shipping, TRIGA-S organises your study logistics to ensure regulatory and customs compliance, with full chain-of-custody traceability for every shipment – even for the transport of hazardous goods.
Your Advantages With TRIGA-S
- We ensure on-time delivery and full chain-of-custody traceability worldwide.
- Your samples remain in secure cold chains throughout temperature-controlled transport.
- Validated kits with verified barcodes and pre-shipment quality checks reduce errors at test sites.
- Stay flexible – no minimum quantities, even for last-minute changes and individual orders.
Fit-for-Purpose Data for Technical Documentation
Test Development, Verification, and Validation
With clear criteria and lean studies, we support your test development, verification, and validation under the IVDR – from initial concept to market readiness. You receive robust evidence from analytical and clinical performance studies, along with audit-ready reports ready for inclusion in your technical documentation and submissions.
How We Support You
Test Development: From initial concept to validated method – with support across Proof-of-Concept analyses, feasibility studies, and test optimisation.
Verification and Validation: Robust assessment of precision, sensitivity, and specificity, method comparisons for platform selection, and clinical performance studies with defined endpoints – so your IVD stands up to conformity assessment by the Notified Body.
Documentation and Regulatory Affairs: Structured study reports ready for inclusion in your technical documentation, with support in your interactions with Notified Bodies and regulatory authorities.
All Services from a Single Source
Complete Solutions
For complex IVD projects, having all services from a single source can be a decisive advantage:
- A single point of contact for all service areas – no coordination effort across multiple service providers
- Consistent data and sample integrity across all process steps
- Shorter project timelines through aligned processes and shared systems
Expert Knowledge for You and Your Team
Workshops That Advance Your Project
We offer hands-on workshops on selected topics in IVD studies, regulatory affairs, biostatistics, and clinical evidence – tailored to your context to help you gain orientation faster.
"Good diagnostics improve lives – and that is exactly what we work for every day. With our in-house BSL-2 laboratory, ISO 13485 certification, and over 25 years of IVD expertise, we deliver the robust evidence you need to pass audits, unlock markets, and shape the diagnostics of tomorrow."
– Dr. Andreas Franke, Managing Director / COO
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
Send Us a Message
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About Us
Diagnostics
Pharma
Abbreviations
BSL-2 Laboratory: Contract laboratory operating at Biosafety Level 2 (BSL-2)
CDx: Companion Diagnostics
CFR: Code of Federal Regulations
CLSI: Clinical and Laboratory Standards Institute
CRO: Contract Research Organisation
EDC: Electronic Data Capture
eCRF: electronic Case Report Form
ISO: International Organization for Standardization
IVDs: in vitro diagnostics
IVDR: In Vitro Diagnostic Regulation
PMPF: Post-Market Performance Follow-up
R&D: Research & Development
SAP: Statistical Analysis Plan
SAR: Statistical Analysis Report
