Our process
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.
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.
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.
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.
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.
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.
Final Delivery
You will receive robust, well-documented results for reports, publications, or audits. The final outputs are technically comprehensible, verifiable, and reusable.
01
Inquiry & Initial Assessment
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.
02
One-on-one consultation with an expert
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.
03
Statistical Implementation
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.
04
Review & Feedback
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.
05
Final Delivery
Final Delivery
You will receive robust, well-documented results for reports, publications, or audits. The final outputs are technically comprehensible, verifiable, and reusable.
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.
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.
Regina Hollweck
Senior statistician
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.
Clinical trials &
biostatistics in the process
with NOVUSTAT
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.
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.
Please let us know your requirements.
