Audit-ready analysis plans and reproducible results
Biostatistics & evidence for successful studies and regulatory submissions
We provide biostatistical support in line with current guidelines—from sample size planning and randomization to Statistical Analysis Plans (SAPs) and analyses.
You receive submission-ready, validated results with auditable documentation, reproducible calculations, and clear visualizations—so you can execute your study successfully.
Tailored exactly to your needs!
All our services can be booked individually or as a complete package.
This applies to both pivotal studies and projects from academic or technological research: we provide targeted support, regardless of whether your studies are subject to regulatory requirements or pursue purely scientific questions.
Your advantages with TRIGA-S
Submission-ready evidence
Statistical Analysis Plans (SAPs) and Statistical Analysis Reports (SARs), as well as audit-ready, validated analyses you can submit directly to competent authorities.
Reduced study risks
Conservative sample size planning according to current guidelines and clear acceptance criteria minimize the risk of additional recruitment and early study termination.
Faster decisions
Clear visualizations and coordinated processes across data collection, data review, and analysis—you always know where you stand.
Efficient execution
When planning, monitoring, and analysis work seamlessly together, you save time and avoid rework.
Traceable and audit-ready
Every assumption is documented, every calculation reproducible—for complete traceability during audits and regulatory inquiries.
Our services in detail
Biostatistics & evidence
All services at a glance—jump straight to the topic you need.
Biostatistical Consulting: Study Planning and Design
Study Design and Endpoints
We translate complex regulatory requirements, such as those of the IVDR, and your individual product goals into robust endpoints (e.g., sensitivity/specificity), analysis populations, and acceptance criteria. We follow international standards like ISO 20916 so that you know from the start which data must be collected to generate evidence.
Sample Size
As little as possible, as much as necessary: we plan your sample sizes according to current guidelines, such as CLSI or FDA requirements, always conservatively, with a buffer and clearly documented assumptions. The goal is to avoid additional recruitment.
Statistical Analysis Plan
A Statistical Analysis Plan (SAP) that leaves no questions unanswered: we define datasets for you, establish statistical methods, specify how missing data is handled, and define the reporting format. The SAP can be part of the protocol or maintained separately.
Randomization
We provide traceable and reproducible plans, even for complex multi-arm CDx designs. This minimizes bias and ensures a clear audit trail.
Validated & audit-ready for IVDR submissions
Statistical Analysis & Report
We analyze your data according to the SAP. All analyses follow our SOPs, are independently validated, and are fully documented—so they’re audit-ready for regulatory review. If you run your own analyses, we can validate them to ensure the results are ready for submission.
You receive:
- Validated analyses according to internal SOPs
- Audit-ready Statistical Analysis Report (SAR)
- Complete documentation of all analysis steps
- Optional: Validation of your own analyses
Data Visualization
Numbers are good. Clear numbers are better. We build interactive dashboards (e.g., with ShinyApps) that visualize your data. You can use them to monitor study progress and prepare results for presentations.
You can:
- Monitor study data in real time
- Analyze data descriptively
- Visually prepare results for reports
- See where you stand at any time
Post-Market Performance Follow-up (PMPF)
Monitoring your products remains crucial even after market launch: PMPF analyses help ensure the long-term performance and safety. We conduct meta-analyses and systematically evaluate performance data to generate consolidated evidence from multiple sources. This allows us to create statistically sound reports – reliable and audit-ready.
We support you with:
- Systematic evaluation of performance data
- Evidence synthesis across multiple sources
- Audit-ready reports for authorities and internal quality assessments
Workshops
Does your team need a fast start on study design or sample size planning? Do you need to convince stakeholders of your statistical strategy? We offer tailored, compact workshops that are understandable even for non-statisticians.
Possible topics:
- Study design and endpoint definition for diagnostics (IVD/CDx) and pharma
- Sample size planning
- Statistical methods for clinical trials
- Correctly interpreting and communicating analysis results
Get in touch with us
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Email Address
info@triga-s.de
Phone Number
Address
Mühltal 5, 82392 Habach
Contact Form
This might also interest you
Sample Management
Clinical Trial Supply Management
Abbreviations
CDx: Companion Diagnostics
CLSI: Clinical and Laboratory Standards Institute
FDA: Food and Drug Administration
ISO 20916: ISO standard for clinical performance studies of IVDs
IVD: In-vitro diagnostics
IVDR: In Vitro Diagnostic Regulation
PMPF: Post-Market Performance Follow-up
SAP: Statistical Analysis Plan
SAR: Statistical Analysis Report
SOP: Standard Operating Procedure