From R&D analyses for hypothesis generation to complex IVDR CDx studies

Study Services for Pharma: CDx Validation and Modular Support

From exploratory R&D analytics to Companion Diagnostics (CDx) validation: we provide the IVD expertise and reliable study services that pharmaceutical companies need at critical stages – with our own BSL-2 contract laboratory, ISO 13485-certified processes, GCP- and GCLP-compliant conduct, and more than 25 years of experience.

Note: We do not plan or conduct medicinal product studies under the AMG/CTR. Analyses are performed for research purposes.

Quality, Compliance, Experience – Ensuring Your Studies Run Smoothly

ISO 13485-Certified

GCP/GCLP-Compliant Processes

In-House BSL-2 Contract Laboratory

25+ Years of Experience

CDx & Study Services – Modular, Scalable, Reliable

Teams come to us with different needs: CDx questions under IVDR, or reliable support for specific work packages within ongoing clinical trials, such as sample collection studies, biostatistical planning, sample management and storage, as well as logistics. We support both – modular and scalable.

CDx Development in Parallel with Therapeutic Development

Two workstreams, one timeline. Companion Diagnostics validation usually needs to be aligned with the timing of the medicinal product study. With TRIGA-S, you have a partner by your side who understands the regulatory requirements and secures CDx milestones – from study planning under IVDR or CFR to the submission-ready study report for integration into your Technical Documentation or Design History File (DHF) (co-approval support for the CDx component).

Modular Study Support

Operational building blocks where you need them – sample collection studies, collection kits & logistics, sample management & processing, sample storage, biostatistics & data management, and R&D analytics in our BSL-2 laboratory. Our team is set up to handle short-notice requests and brings in-depth expertise to your project at any stage.

Time Management That Keeps Your Project on Track

Time-to-market, tight study timelines, resource peaks, and critical dependencies: We keep things moving with fast response times, robust timelines, and scalable capacity – without compromising on quality.

Minimising Operational Risks in Studies

Pre-analytics, international logistics including customs clearance, cold chain management, labelling and site coordination – we take full responsibility for these processes. With extensive experience in international study projects, documented traceability, and well-established workflows, we ensure that your study data is reliable and submission-ready.

Why pharmaceutical companies rely on TRIGA-S

EMPOWERING HEALTHCARE TOGETHER

Behind every therapeutic is a goal: the right therapy for the right patient. This calls for a partner who understands IVD regulations, is experienced in CDx studies, and adapts to your pace. TRIGA-S combines IVDR know-how with operational study efficiency – for CDx validations and for modular components in your clinical trials. Collaborative, responsive, and audit-ready.

Specialised in CDx Performance Studies

Study planning, pre-study submissions, validation – as a specialised Contract Research Organisation (CRO), we have been working at the interface of IVD and pharma for years. This expertise feeds directly into your project.

In-House BSL-2 Laboratory

Our ISO 13485-certified BSL-2 contract laboratory is equipped for
analyses for research and development purposes and enables contract testing with no minimum quantities and no detours through external service providers.

Modular or Complete

From a single measurement to full validation: You book what you need. Even for short-notice requests, plan changes, or standalone assignments, we adapt to your project needs – not the other way around.

Collaborative and Personal

Direct accessibility, fast response channels, and dedicated points of contact: You always speak to the people who know and manage your project.

In Early Research Phases, Through Clinical Trials, and To Demanding CDx Validations – We Are by Your Side

Our Services for Pharmaceutical Companies

We provide all services individually or as part of comprehensive CDx support. We support your project exactly where you need us.

Not sure where to start? Get in touch – we’ll find the right solution together.

CDx Study Planning & Monitoring

We handle protocol development, submissions to ethics committees and authorities, and ongoing monitoring. The result is a study report that can be incorporated directly into your regulatory submission documents.

Sample Management, Processing & Logistics

We procure, process, and store clinical samples with full chain-of-custody traceability and precise aliquoting. We take care of the shipment (temperature controlled) and the corresponding documentation – domestically and internationally, including customs clearance.

R&D Analytics

Exploratory readouts, stability and matrix studies, and method and platform checks are all possible in our BSL-2 laboratory – with no minimum quantities and no long lead times. Please note: All analyses are performed for research and development purposes and not for diagnostic decisions.

Biostatistics & Data Management

Our biostatisticians are involved from the start: sample size planning, randomisation, SAP development, and validated evaluations – in clinical trials including CDx performance studies. In data management, we handle eCRF design and EDC setup, plausibility checks, and query management, as well as LIMS/eTMF integration with full audit trail. The foundation: an ISO 13485 QMS, GCP/GCLP-compliant processes, and GDPR-compliant data hosting.

Collection Kits & Study Material

We assemble collection kits, handle GCP-compliant documentation, and ship kits to trial sites worldwide – always on time, reliably, and with full traceability.

Regulatory Support

We handle the regulatory complexities so your approval process runs smoothly: FDA/EMA co-approval support, communication with regulatory authorities, and the preparation of CDx-specific documentation in compliance with IVDR.

IVD Expertise On Demand

Need IVD-specific expertise for a limited period? Our specialists can hit the ground running – no lengthy onboarding required.

How We Work With You

CDx projects and studies come to us at every phase. That is why we never start with a standard process – we start by taking a close look at your specific situation.

Initial Consultation & Needs Analysis

First, we discuss your CDx project, the status of your hypothesis, and your regulatory goals. We listen, ask the right questions, and propose the most suitable approach.

Joint Alignment Meeting

Depending on your needs, we involve our colleagues from study management, regulatory affairs, biostatistics, and the laboratory – always with a view to your CDx development plan. This ensures that study type, timeline, and conformity assessment are aligned and robustly planned from the outset.

Proposal & Project Start

Based on the conversations, you will receive a tailored proposal – whether you are testing an initial biomarker hypothesis, preparing CDx study documents for submission, or need advisory support. Once the contract is in place, we can start right away with the kick-off.

“When a pharmaceutical company approaches us with enquiries about CDx trials, a drug trial is often already underway in Phase I or II. At this point, it is crucial to align the Phase III drug development study with the CDx performance studies. This is where we bring the diagnostic expertise, flexibility, and speed that make all the difference.”

– 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

sales@triga-s.de

Phone Number

+49 (0) 88 47 – 695 78 0

Address

TRIGA-S GmbH
Mühltal 5, 82392 Habach, Germany

Send Us a Message

Outlook appointment booking

Speak to 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 them together.

Current Project Status

Where are you in your project right now? Whether you are still generating or validating your hypothesis, preparing for a study, or need support for an already ongoing study – we meet you where you are.

Your Regulatory Goals

Are you planning to seek regulatory approval for the therapeutic in the EU, the US, or both? How are the CDx and medicinal product development milestones aligned? This affects the study design, evidence requirements, documentation, and timeline.

Trial Sites & Locations

In which countries do you plan to conduct your study? Do you already have specific trial sites in mind, or are you still looking? We support site selection and coordination – even at 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
Support with an analytical performance study for a CDx
Support with a clinical performance study for a CDx
Study-related regulatory affairs & communication with authorities