Certainty from Planning to the Final Report
IVD Study Management & Monitoring with TRIGA-S
TRIGA-S supports your study management from planning through the final report. You will receive audit- and submission-ready study documentation in compliance with ISO 20916, IVDR, and CFR.
All our services can be booked individually or as a complete package – precisely according to your needs.
Your Benefits with TRIGA-S
Regulatory Confidence from Day One
Your study meets all current requirements: ISO 20916:2024, IVDR, and CFR. We know the pitfalls and proactively eliminate them.
Audit-Proof Data Quality
Complete, traceable documentation (TMF/eTMF), risk-based monitoring, and real-time dashboards give you continuous oversight and data integrity that stands up to any audit.
Faster Market Access
Structured data collection forms, careful site selection before study start, and thorough preparations by our well-coordinated team shorten setup times and minimize rework.
On-Time Delivery
We identify risks early, preventing unnecessary project delays. This keeps your processes predictable and avoids costly surprises.
Our services in detail
Study Management & Monitoring
All services at a glance – jump straight to the topic you need.
Study Design & Planning
Getting it right from the start makes all the difference. A well-conceived, scientifically sound study design based on current literature and regulatory requirements is the foundation for your success.
We integrate data collection, monitoring, and analysis into one streamlined workflow for these study types:
- Exploratory Study
- Feasibility Study
- Sample Collection Study
- Analytical Performance Study
- Clinical Performance Study
- Companion Diagnostics (CDx) Study
- Usability Study
- Post-Market Performance Follow-up (PMPF) Study
“Across all study types, we apply risk-based planning and oversight to proactively address critical aspects – optimising resource use and ensuring smooth processes that keep your studies moving forward efficiently.”
– Dr. Lisa Mutschelknaus, Head of Study Management
Study Preparation
A study’s success is not determined at the point of evaluation – it is shaped long before the first sample analysis. Our preparation sets the foundation for efficient execution and regulatory acceptance, while systematically reducing follow-up questions from authorities and ethics committees.
We create all necessary documents according to current standards – compliant, complete, and in time for a smooth study start.
Site Selection and Management
A study only succeeds with sites that truly fit your requirements. That’s why structured site management matters – ensuring reliable site selection and hands-on support at every stage.
While protocols and regulations form the foundation, the people and processes on site determine recruitment, data quality, and ultimately the study’s success.
We support you from site identification to the final study report, ensuring you have the right partners on board.
Suitable Study Sites
We identify the right study sites for your clinical performance study based on the target group, geographical requirements, and professional specializations.
Site Assessment
We systematically assess equipment, resources, and capacity to ensure each site meets your requirements.
Cross-Site Coordination
We ensure recruitment, sample flows, and data quality across all sites.
On-Site Presence
Our CRAs (Clinical Research Associates) ensure compliance through close contact with study sites and targeted on-site visits.
Study Monitoring
Monitoring ensures data quality and regulatory compliance. With TRIGA-S, you maintain an overview of your study data at all times.
What our monitoring expertise covers:
Tailored Monitoring Plans
We define the scope, frequency, and priorities of monitoring activities – risk-based, targeted, and efficient.
Complete Documentation
We manage your Trial Master Files (TMF/eTMF) and ensure a complete, auditable documentation set.
Structured Site Visits
Our site initiation, monitoring, and close-out visits ensure compliance and data quality at each site.
Source Data Verification (SDV)
We verify that collected data accurately reflect the source data – fully audit-ready.
Professional Query Management
We provide ongoing support for your data capture system, perform plausibility checks and data cleaning, ensuring high data quality and rapid query resolution.
Real-Time Transparency
Dashboards provide real-time status on recruitment, completeness, and deviations.
Central Data Collection
Reduce workload and errors by delegating data capture for clearly defined components (central laboratory data, logistics data, transcription, data imports) to our team – including training and support for study sites to shorten turnaround times.
Regulatory Support
The regulatory landscape is complex – staying on top of IVDR, FDA requirements, and national specifics is a constant challenge.
We guide you through the regulatory landscape and keep your conformity assessment on track.
The Challenge
Complex authority requirements and regulatory specifications
Our Solution for You
Complete, submission-ready documents for ethics committees and authorities.
The Challenge
Returns and delays due to incomplete documents
Our Solution for You
Scientific consultations with BfArM, PEI, and FDA to precisely clarify requirements and minimize delays.
The Challenge
Uncertainty in implementing requirements from IVDR or MDCG documents
Our Solution for You
Classification and IVDR gap analyses of your technical documentation to ensure IVDR conformity and make CE marking predictable.
The Challenge
FDA market entry for USA expansion
Our Solution for You
Comprehensive support in meeting FDA requirements for successful US market entry.
“With over ten years of experience, I know firsthand: overlooking one critical detail in the planning phase can send your regulatory strategy off course – and the effects can ripple through the entire process. At TRIGA-S, we set the right course early on: with structured planning and meticulous attention to detail.”
– Dr. Stefanie Gaupp, Team Lead Study Management
Study Completion and Reporting
Studies do not end with the last measurement. We close them properly – database closure, final verified datasets, and a Performance Study Report suitable for technical documentation. The result: a strong basis for conformity assessment, audits, and post-market activities.
Our deliverables include:
- Performance Study Report in accordance with regulatory requirements for your technical documentation
- Database Closure with final, verified datasets
- Full traceability across all processes – audit- and inspection-ready
Data Quality and Data Protection Standards
All our services are delivered in compliance with the following quality and data protection standards:
ALCOA++
GDPR-Compliant Hosting (Servers in Germany/EU)
Complete Traceability of All Processes
Integrity, Availability, and Compliance at Every Step
True Partnership is the Foundation for Strong Study Results
“Patients, physicians, researchers – every study is backed by people who rely on precise results. That's why every study project is a true partnership for us – one whose trust is grounded in scientific precision. Let’s talk about your study.”
– 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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Abbreviations
ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate
APSP: Analytical Performance Study Plan
BfArM: Federal Institute for Drugs and Medical Devices
CDx: Companion Diagnostics
CE: European Conformity
CFR: Code of Federal Regulations
CPSP: Clinical Performance Study Plan
CRA: Clinical Research Associate
DMP: Data Management Plan
GDPR: General Data Protection Regulation
eCRF: Electronic Case Report Form
EDC: Electronic Data Capture
eTMF: Electronic Trial Master File
EU: European Union
FDA: Food and Drug Administration
ICF: Informed Consent Form
ISO: International Organization for Standardization
IVD: In vitro diagnostics
IVDR: In Vitro Diagnostic Regulation
MDCG: Medical Device Coordination Group
PEI: Paul-Ehrlich-Institut
PMPF: Post-Market Performance Follow-up
SDV: Source Data Verification
TMF: Trial Master File
US: United States
