TRIGA-S: Your Specialist CRO Partner – from Study Planning to Final Report
IVDR-Compliant Performance Studies for Market Access
Are you developing an in vitro diagnostic and need robust study data for IVDR-compliant market access?
TRIGA-S plans, coordinates, and conducts analytical and clinical performance studies – including sample management and storage as well as audit-ready documentation. We also support you with sample collection studies, usability studies, and post-market performance follow-up studies. Available as individual modules or as a full-service package – tailored to your current project stage.
Quality, Compliance, Experience – for Diagnostic Companies & IVD Manufacturers:
ISO 13485-Certified
GCP/GCLP-Compliant
Own BSL-2 Laboratory
25+ Years of Experience
Proven in Practice & technology-agnostic
Device Types We Work With
Our team receives regular training on new diagnostic technologies and has extensive experience with:
Point of Care (POC) | Molecular Dx (quantitative PCR / Multiplex qPCR) | Immunoassays (ELISA, Chemiluminescence) | Clinical Chemistry Assays | Sample Collection Devices | Lateral Flow Assays (LFA)
Overcoming Challenges Together
Your Path to IVDR Compliance
Study design, evidence requirements, and documentation – the path to IVDR compliance is demanding and complex. Whether it’s time pressure, limited resources, or uncertainty in dealing with Notified Bodies – we know the challenges.
Through technical expertise and structured study planning, we ensure you obtain robust evidence of your product’s performance – the foundation for conformity assessment and market access.
Why diagnostic companies and IVD manufacturers rely on TRIGA-S
Empowering Diagnostics Together
Behind every IVD product is an idea – one that exists to help patients. For it to reach the market, it takes more than a study protocol: it takes someone who understands your product, knows the regulatory requirements, and conducts studies that are scientifically rigorous and submission-ready.
With TRIGA-S, your product is in the right hands.
Regulatory Security Right From the Start
Our ISO 13485 certification is the foundation of our work. We operate in compliance with GCP/GCLP with an ISO 13485-compliant QMS and audit-ready documentation. Sound study design and reliable statistics minimise the risk of additional requests from Notified Bodies.
In-House BSL-2 Laboratory
Our own BSL-2 laboratory enables fast, independent analytics without detours through external service providers. We cover immunoassays, clinical chemistry, ELISA, and RT-PCR and can establish analytical studies and contract testing at short notice.
25+ years of IVD Expertise
For over 25 years, we have conducted IVD studies in changing regulatory landscapes, for a wide variety of product categories and risk classes. This knowledge flows into every study design: from sample size calculation to the risk class-specific expectations of Notified Bodies.
Flexible, Even When Your Project Changes
Short-notice requests, small individual orders, project changes – we know the realities of complex development. Our commitment: We adapt to your needs, not the other way around.
True Partnership, True Collaboration
You have dedicated contacts at TRIGA-S: people who know your project and think along with you. Regular consultations, transparent communication, and direct accessibility are a matter of course for us. No ticket systems, no anonymous processing.
Your Indication Areas. Our Expertise.
Infectious Diseases
Oncology
Neurodegeneration
Gynecology & Reproductive Medicine
Sepsis
Immunology / Allergology
Study Planning, Sample Management, Analysis, Final Report – Modular, From a Single Source
Our Service Portfolio for Diagnostic Companies and IVD Manufacturers
Our services are fully modular – choose exactly what your project needs, whether individual services or complete study support.
Not sure where to start? Get in touch – we’ll find the right solution together.
Clinical Performance Studies
We plan and conduct clinical performance studies according to ISO 20916, IVDR, and GCP: from protocol development through site management and monitoring to submission-ready study reports. You receive audit-ready documents and a partner who identifies and resolves regulatory risks early. We also offer sample collection studies, usability studies, and post-market performance follow-up studies.
Analytical Performance Studies
Precision, sensitivity, specificity, method comparison: We design analytical performance studies so that the results flow directly into your technical documentation. Guideline-compliant, reproducible, and with clear acceptance criteria – no unnecessary rework
Study Design & Protocol Development
A solid study design saves time, money, and stress. We translate regulatory requirements and your product goals into scientifically sound protocols – and align endpoints, sample sizes, and data flows so that all study phases build on each other seamlessly.
Sample Management & Processing
Complete documentation, controlled storage from -90°C to room temperature, aliquoting down to the microliter range, and tailored sample panels: Every sample is available at the right time in the right quality – including kit assembly and logistics as a complete service.
Study Management & Monitoring
We manage your study operationally and keep recruitment, data quality, and timelines under control – with dedicated contacts, risk-based monitoring, site visits, query management, and real-time dashboards. You focus on your product and we take care of the rest.
Biostatistics & Data Management
Robust sample size planning, audit-ready analysis plans, validated evaluations, and submission-ready reports: Our biostatisticians work closely with the study team from the start. This ensures that statistical requirements are built into the protocol from day one, not added during analysis.
Contract Measurements in the BSL-2 Laboratory
In our own BSL-2 laboratory, we perform contract testing – with no minimum quantities and ISO 13485-audited quality. Whether feasibility study, proof of concept, or part of a multicenter study: You receive reliable data, quickly and without detours.
Regulatory Support
We know the regulatory landscape and guide you so that your path to approval stays on track. IVDR gap analyses, regulatory communication, TMF/eTMF management, ethics submissions, classification, FDA requirements (CFR): We handle the regulatory complexity.
Specialised Expertise on Demand
Facing a capacity bottleneck, covering parental leave, or working on a project that requires specialist expertise? We provide you with experienced professionals from study management, biostatistics, regulatory affairs, monitoring, logistics, or laboratory operations – seamlessly integrated into your operations, for as long as you need us.
How We Work Together
From the first enquiry to the submission-ready report, we are transparent, structured, and always accessible – with a dedicated point of contact throughout.
• You have a synopsis? We develop a study protocol.
• You already have a protocol? Let's start immediately.
• You are right at the start of your project? No problem. We begin with a joint workshop to analyse the status quo and find the best path forward.
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
"We don't just run studies. We want to understand your regulatory strategy and pave the way to CE marking together with you."
– 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
Outlook appointment booking
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.
Would you like to prepare for our conversation?
To give you concrete guidance from the very first conversation, it helps if you bring the following information. Don’t worry: If individual points are still open, we will clarify the questions together.
Your Investigational Product
What do you want to test, how many investigational products are involved, and what information is already available? If you already have a draft intended purpose – even better. Send it over and we’ll review it ahead of our call.
Current Project Status
Where do you currently stand? Whether you’re still in product development, preparing for a study, or need support for an already ongoing study – we meet you where you are.
Your Objectives
Are you planning to place an IVD on the market in the EU, the USA, or both? This influences study design, documentation, and timeline.
Trial Sites & Locations
In which countries should your study take place? Do you already have investigational sites in mind or are you still searching? We support site selection and coordination – even on short notice and internationally.
Desired Support From TRIGA-S
Where do you need support? The more precisely you can describe your needs, the more targeted our advice will be from the outset.
- Consulting & study design
- Preparation of an analytical performance study
- Conduct of an analytical performance study
- Preparation of a clinical performance study
- Conduct of a clinical performance study
- Study-related regulatory affairs & communication with authorities
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Abbreviations
BSL-2 Laboratory: Contract laboratory operating at Biosafety Level 2 (BSL-2)
CE: European Conformity
CFR: Code of Federal Regulations
CRO: Contract Research Organisation
Dx: Diagnostics
ELISA: Enzyme-linked Immunosorbent Assay
eTMF: Electronic Trial Master File
FDA: Food and Drug Administration
GCP: Good Clinical Practice
GCLP: Good Clinical Laboratory Practice
ISO: International Organization for Standardization
IVD: In vitro diagnostics
IVDR: In Vitro Diagnostic Regulation
LFA: Lateral Flow Assay
PCR: Polymerase Chain Reaction
POC: Point of Care
QMS: Quality Management System
qPCR: quantitative Polymerase Chain Reaction
RT-PCR: Real-time quantitative Polymerase Chain Reaction
TMF: Trial Master File
