Audit-ready analysis plans and reproducible results

Biostatistics & Evidence for Successful Studies and Regulatory Submissions

We provide biostatistical support in line with the latest guidelines, covering everything from sample size planning and randomisation to Statistical Analysis Plans (SAPs) and analyses.

You will receive submission-ready, validated results with auditable documentation, reproducible calculations and clear visualisations, enabling you to execute your study successfully.

Tailored Exactly to Your Needs!

All of our services can be booked either individually or as a complete package.

This applies to pivotal studies and projects in academic and technological research. We provide targeted support, whether your studies are subject to regulatory requirements or are purely scientific in nature.

Your Benefits with TRIGA-S

Evidence Ready for Submission

We provide Statistical Analysis Plans (SAPs) and Statistical Analysis Reports (SARs), as well as validated analyses that are ready for audit and can be submitted directly to competent authorities.

Reduced Study Risks

Conservative sample size planning and clear acceptance criteria, in line with current guidelines, minimise the risk of additional recruitment and early study termination.

Make Faster Decisions

Thanks to clear visualisations and coordinated processes across data collection, review and analysis, you always know where you stand.

Efficient Execution

When planning, monitoring and analysis work together seamlessly, you save time and avoid unnecessary work.

Traceable and Audit-Ready

Every assumption is documented and every calculation is reproducible, ensuring 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. By following international standards such as ISO 20916, we ensure that you know from the outset 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. Our approach is always conservative, with a buffer and clearly documented assumptions. Our goal is to avoid the need for additional recruitment.

Statistical Analysis Plan

Our Statistical Analysis Plan (SAP) leaves no stone unturned: we define your datasets, establish statistical methods, specify how missing data is handled and determine the reporting format. The SAP can either be incorporated into the protocol or maintained separately.

Randomisation

We provide traceable and reproducible plans, even for complex multi-arm CDx designs. This minimises bias and ensures a clear audit trail.

Your Data: Validated & audit-ready

Statistical Analysis & Report

We analyse your data in accordance with the SAP. All analyses follow our SOPs, are independently validated and fully documented, making them audit-ready for regulatory review. If you perform your own analyses, we can validate them to ensure the results are fit for submission.

You will 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 Visualisation

Numbers are good. Clear numbers are better. We build interactive dashboards that visualise your data. You can use them to monitor study progress and prepare results for presentations.

You can:

Monitor study data in real time
Analyse data descriptively
Visually prepare results for reports
See where you stand at any time

Post-Market Performance Follow-up (PMPF)

Even after market launch, monitoring your products remains crucial. PMPF analyses help to ensure long-term performance and safety. We conduct meta-analyses and systematically evaluate performance data to generate consolidated evidence from multiple sources. This enables us to produce reliable, audit-ready reports that are statistically sound.

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 assistance with study design or sample size planning? Do you need assistance in convincing stakeholders of your statistical strategy? Our workshops can be tailored to your specific requirements and are accessible to non-statisticians.

Possible topics include:

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

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