Personalized support. Clearly structured. Methodologically sound.

Our process

From the initial inquiry to a methodologically sound publication.

NOVUSTAT Video Outline on Collaboration on Statistical Projects

The CONSORT logo indicates transparent reporting of clinical trials at NOVUSTAT.

The GCP logo indicates compliance with Good Clinical Practice in clinical trials and medical research conducted with NOVUSTAT.

The ICH logo indicates compliance with regulatory standards in clinical research and biostatistics at NOVUSTAT.

NOVUSTAT supports your project with a dedicated point of contact and statistical expertise—from the initial assessment through statistical implementation to the publication of methodologically sound results.

✓
One-stop statistical service:
We provide reliable support every step of the way—from study design and analysis to documentation and publication.
✓
Flexible Start:
Support for new and ongoing projects, tailored to your current status.
✓
Designated Contact Person:
Direct communication with an experienced specialist throughout the entire project.
✓
Validated processes:
Transparent workflows, documented analyses, and reliable statistical results.
✓
Secure Data Processing:
Confidential processing, secure transmission, and clear data protection policies.

Novustat_Logo_Blue1

5 steps to sound statistics.

Successful statistical collaboration is based on clearly defined processes and transparent communication. Especially in complex clinical, scientific, or data-driven projects, a structured approach is crucial for quality, traceability, and planning reliability.





A NOVUSTAT employee on the phone to handle a free inquiry and provide an initial assessment of a statistics project.

01
Step 01 of 05

Reviewed free of charge.

Inquiry &
Initial Assessment

NOVUSTAT will review your inquiry free of charge and provide a technical assessment of your project. In doing so, we will take a structured look at the research question, available data, objectives, and potential methodological requirements so that you can obtain reliable guidance on the next steps early on.

✓Freeinitial assessment of your project
✓Technicalevaluation of the research question and available data
✓Assessmentof Feasibility and Methodology
✓Initialassessment of the effort required and the next step


Request a no-obligation project quote now
›

NOVUSTAT: One-on-one consultation with an expert on statistical project planning with a physician in the conference room.

02
Step 02 of 05

Personalized advice.

Personal Expert Discussion

Through one-on-one discussions, we define the objectives, study design, scope of analysis, and project structure. This establishes a shared technical foundation upon which methodology, timelines, and responsibilities can be clearly agreed upon.

✓Consultingon design, methodology, and objectives
✓Clarificationof hypotheses, endpoints, and variables
✓Coordinationof timelines and milestones
✓Definitionof the form of cooperation


Meet Our Statisticians
›

NOVUSTAT Step 3: Statistical implementation with structured data analysis and expert evaluation.

03
Step 03 of 05

Implemented methodically.

Statistical
Implementation

NOVUSTAT implements the agreed-upon statistical methodology in a structured, transparent, and reproducible manner. The analysis is conducted based on clearly defined analytical pathways and documented decisions.

✓Structureddata preparation and validity checks
✓Conductingdefined analyses and modeling
✓Validatedand reproducible workflows
✓Fullydocumented results


Why choose NOVUSTAT for implementation?
›

NOVUSTAT: A consultation meeting to transparently discuss statistical results with a physician in the conference room.

04
Step 04 of 05

Coordinated transparently.

Review & Feedback

Results, intermediate steps, and methodological decisions are explained transparently and agreed upon collaboratively. This ensures that you remain involved in the technical aspects throughout the implementation process.

✓Regularprogress updates and review of results
✓Clearexplanation of statistical decisions
✓Adjustmentsin response to new data or changing conditions
✓A dedicatedpoint of contact throughout all project phases


View references on our collaborations
›

NOVUSTAT: Final delivery of statistical results, including a results report and documentation suitable for publication.

05
Step 5 of 5

Delivered in a form ready for publication.

's Final Delivery

You will receive robust, well-documented results for reports, publications, or audits. The final outputs are technically comprehensible, verifiable, and reusable.

✓Finalresults report with tables and figures
✓Documentedanalyses and modeling decisions
✓Reproducibleoutputs, including syntax or code
✓Supportwith publication, review, or questions


View Successful Projects
›

01
Inquiry & Initial Assessment

A NOVUSTAT employee on the phone to handle a free inquiry and provide an initial assessment of a statistics project.
Reviewed free of charge.

Inquiry & Initial Assessment

NOVUSTAT will review your inquiry free of charge and provide a technical assessment of your project. This involves a structured analysis of the research question, available data, objectives, and potential methodological requirements.

Free Initial Assessment of Your Project
Technical Assessment of the Research Question and Available Data
Assessment of Feasibility and Methodology
Initial Assessment of the Effort Required and Next Steps

Request a no-obligation project quote now

02
One-on-one consultation with an expert

NOVUSTAT: One-on-one consultation with an expert on statistical project planning with a physician in the conference room.
Personalized advice.

One-on-one consultation with an expert

Through personal discussions, we define the objectives, study design, scope of analysis, and project structure. This establishes a shared professional foundation for methodology, timelines, and responsibilities.

Consulting on Design, Methodology, and Objectives
Clarification of Hypotheses, Endpoints, and Variables
Coordination of Timeframes and Milestones
Definition of the Form of Cooperation

Meet Our Statisticians

03
Statistical Implementation

NOVUSTAT Step 3: Statistical Implementation – Dr. Grünwald conducts statistical evaluation and data analysis.
Implemented methodically.

Statistical Implementation

NOVUSTAT implements the agreed-upon statistical methodology in a structured, transparent, and reproducible manner. The analysis is conducted based on clearly defined analytical pathways and documented decisions.

Structured Data Preparation and Validation
Conducting defined analyses and modeling
Validated and reproducible workflows
Fully documented results

Why choose NOVUSTAT for implementation?

04
Review & Feedback

NOVUSTAT: A consultation meeting to transparently discuss statistical results with a physician in the conference room.
Coordinated transparently.

Review & Feedback

Results, intermediate steps, and methodological decisions are explained transparently and agreed upon collaboratively. This ensures that you remain involved in the technical aspects throughout the implementation process.

Regular progress updates and results reviews
Clear Explanation of Statistical Decisions
Adjustments in Response to New Data or Changing Circumstances
A dedicated point of contact throughout all project phases

View references regarding our collaboration

05
Final Delivery

NOVUSTAT: Final delivery of statistical results, including a results report and documentation suitable for publication.
Delivered in a form ready for publication.

Final Delivery

You will receive robust, well-documented results for reports, publications, or audits. The final outputs are technically comprehensible, verifiable, and reusable.

Final Results Report with Tables and Figures
Fully documented analyses and modeling decisions
Reproducible outputs, including syntax or code
Assistance with publication, reviews, or inquiries

View Successful Projects

Data Security & Confidentiality

At NOVUSTAT, sensitive research data and project data are processed in a structured manner, documented in a traceable way, and handled in accordance with applicable data protection requirements and regulatory guidelines. This ensures that your data remains protected and is documented in a verifiable manner throughout all project phases.

Your data remains protected.
Your results remain reliable.

GDPR-Compliant Data Processing

In accordance with the General Data Protection Regulation and regulatory requirements.

Secure Transmission & Access

Encrypted transmission and finely tuned access control policies.

Confidentiality Agreements

Binding NDAs and structured safeguards.

Documented in a manner suitable for an audit

Complete traceability and transparency for internal and external audits.

Novustat Chart Quote

Regina Hollweck

Senior statistician

Regina Hollweck, Senior Statistician at NOVUSTAT, is the contact person for statistical consulting and a free initial assessment.

Free Initial Assessment

Your first step toward
statistical support.

Start with a no-obligation expert assessment of your project. NOVUSTAT will review your research question, data, and objectives, and show you which statistical approach makes the most sense for the next steps.

Methodological quality and safety.

Clinical trials &
biostatistics in the process
with NOVUSTAT

From study planning and analysis
to the preparation of results for publication.

Clinical trials and biostatistical projects follow a clear statistical workflow. NOVUSTAT supports key project phases—from study design through data analysis and documentation to the preparation of publishable results —with methodological precision and regulatory expertise.

The CONSORT logo indicates transparent reporting of clinical trials at NOVUSTAT.

The GCP logo indicates compliance with Good Clinical Practice in clinical trials and medical research conducted with NOVUSTAT.

The ICH logo indicates compliance with regulatory standards in clinical research and biostatistics at NOVUSTAT.

Dr. Robert Grünwald von NOVUSTAT als Ansprechpartner für Biostatistik, medizinische Biometrie und klinische Studien im regulatorischen Kontext.

Biostatistics throughout the phases of a clinical project

This overview shows how NOVUSTAT supports clinical trials and biostatistical projects from planning through data analysis to advanced bioscience analysis.



Planning phase of clinical trials

The methodological quality and regulatory robustness of the entire project are determined during the planning phase of clinical trials. NOVUSTAT provides support in this area with statistical precision and extensive experience.

Statistical support during the planning phase

  • Consulting on primary and secondary endpoints, study design, and sample size planning.
  • Conducting literature searches using defined keywords.
  • Sample Size Planning for Superiority Studies, Confirmatory Studies, and Bioequivalence.
  • Preparation of statistical analysis plans, either in their entirety or as individual chapters.
  • Contributed to the statistical sections of the study protocol.
  • Statistical support for submission and study registration.
  • Planning and implementing appropriate randomization methods.
  • Creation of CRFs, paper CRFs, or eCRFs.

Upon completion of the clinical phase

Once the clinical phase is complete, the focus shifts to data quality, statistical analysis, and transparent documentation of results. NOVUSTAT supports you in the structured preparation and analysis of your study data.

Analysis and documentation of results

  • Review and validation of the available study data.
  • Preparation of data sets for statistical analyses and reports.
  • Conducting descriptive, exploratory, and inferential statistical analyses.
  • Data analysis in accordance with the study objective, analysis plan, or publication requirements.
  • Creation of tables, graphs, and statistical summaries of results.
  • Interpretation of key findings in a medical and methodological context.
  • Documentation of the analytical methods used for a report, study, or publication.
  • Finalizing the results for a study report, manuscript, or other purposes.

Additional services from bio science

In addition to clinical trials, NOVUSTAT also supports biostatistical and bioinformatics projects by providing methodological planning, data analysis, and reproducible presentation of results.

Biostatistics, Bioinformatics, and Research

  • Statistical consulting for medical, scientific, and data-driven questions.
  • Analysis of complex biological, clinical, or experimental datasets.
  • Support for bioinformatics analyses and reproducible workflows.
  • Development of appropriate analytical approaches for research projects and publications.
  • Preparing results for reports, presentations, or scientific publications.
  • Methodological interpretation of statistical results within the relevant academic context.
  • Assistance with inquiries from reviewers, specialized departments, or project partners.
  • A structured presentation of methods, results, and limitations.

Planning Phase

Clinical trial planning phase

Methodological quality and regulatory robustness are established as early as the planning stage.

Statistical Support

  • Consultation on primary and secondary endpoints.
  • Support with study design and sample size planning.
  • Literature searches based on defined keywords.
  • Preparation of statistical analysis plans.
  • Contribution to the statistical section of the study protocol.
  • Assistance with submission and study registration.
  • Planning appropriate randomization methods.
  • Creation of CRFs, paper CRFs, or eCRFs.

Completion of the clinical phase

Completion of the clinical phase

Focus on data quality, statistical analysis, and transparent documentation of results.

Analysis and documentation of results

  • Verification and validation of the study data.
  • Preparing data sets for analysis and reports.
  • Descriptive, exploratory, and inferential statistical analyses.
  • Evaluation in accordance with the study objective or analysis plan.
  • Creation of tables, graphs, and summaries of results.
  • Interpretation of key findings in a specialized context.
  • Documentation of the analytical procedures for a report or publication.
  • Finalizing the results for a research report or manuscript.

Bio Science Services

Additional services from bio science

Biostatistical and bioinformatics projects involving methodological planning and reproducible data analysis.

Biostatistics, Bioinformatics, and Research

  • Statistical consulting for medical and scientific issues.
  • Analysis of biological, clinical, or experimental datasets.
  • Support for bioinformatics analyses.
  • Developing reproducible workflows.
  • Development of appropriate analytical approaches.
  • Preparing results for reports and publications.
  • Methodological Interpretation of Statistical Results.
  • Assistance with inquiries from reviewers or project partners.

More than 3,000 clinics, institutes, and companies rely on NOVUSTAT for clinical and biostatistical projects.

Please let us know your requirements.

You will receive a non-binding quote shortly.

Methodologically sound. Transparent pricing. Handled confidentially.

GDPR-compliant trust element on the NOVUSTAT website