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Biostatistics

Biostatistics and pharmacokinetics support throughout development

Our experienced biostatisticians, statistical programmers and pharmacokinetic analysts enable Nuvisan to provide highest-quality design and analysis of early-phase clinical trials that are both scientifically sound and compliant with regulatory standards, maximising the chances of success for your clinical development program. As a team of dedicated scientists, Nuvisan provides comprehensive support for statistical and pharmacokinetic consultancy from trial design to reporting.
Biostatistics and pharmacokinetics reporting for a clinical trial study report

Critical thinking at every step

Our biostatisticians provide tailored advice based on your specific needs at every critical stage, from the earliest phases of clinical development planning to the final presentation of data. We offer expert guidance to optimise the statistical design and analysis of studies across a wide range of development phases, whether for our in-house clinical trials or stand-alone biostatistical or pharmacokinetic services requests. Our in-house team is co-located with all Nuvisan clinical services teams (project management, medical writing, medical experts, Clinical Pharmacology Unit, data management and monitoring), to help ensure quick and effective communication for all aspects of your project.

Biostatistician analyzing data on a laptop screen in a modern office setting

Let’s discover the primary outcomes of your study together

Our specialised biostatistics unit services include: 
  • Biometrical consulting (regulatory consulting, study design, sample size calculation and statistical analysis)  
  • Input to clinical study protocols (CSPs)
  • Randomisation 
  • Writing of statistical analysis plans (SAPs) (including shells for the outputs) 
  • SAS®-programming of datasets according to CDISC ADaM formats as well as tables, listings and figures for CSRs 
  • Generation and delivery of CDISC ADaM submission package 
  • Pharmacokinetics analysis (evaluation of bioavailability, bioequivalence, biosimilarity, dose proportionality, drug interaction and food effect) 
  • Noncompartmental analysis using Phoenix WinNonlin® 
  • Pharmacodynamics analysis (including biomarkers)  
  • Efficacy analysis 
  • Input to CSR 
  • Writing of biometrical reports 
  • Input to manuscripts.

Related topics & resources

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Clinical Pharmacology Unit

Our clinical pharmacology unit conducts early phase clinical trials for our clients for over 40 years.

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Multicentre patient studies

We provide clinical development support for your multicentre phase 1-2 trials.

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Our trial solutions

Discover how our comprehensive clinical trial services can support your efforts.

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Frequently asked questions (FAQs)

  • What biostatistics and pharmacokinetics services does Nuvisan offer?
    Nuvisan provides biostatistics and pharmacokinetics support across the clinical development process. Services include biometrical consulting, study design, sample size calculation, statistical analysis, pharmacokinetic and pharmacodynamic evaluation, as well as preparation of statistical reports. We also support clinical study protocols, statistical analysis plans and regulatory submission packages. In addition to full-service support, we deliver standalone pharmacokinetic projects.
  • At which stages of clinical development can Nuvisan biostatisticians support a study?
    Nuvisan biostatisticians support studies at each key stage of development, from early planning and study design through to data analysis and final reporting. The team provides tailored advice to strengthen statistical strategy and support scientifically robust results that meet regulatory requirements.
  • How does Nuvisan ensure high-quality statistical analysis for clinical trials?
    Nuvisan brings together experienced biostatisticians, statistical programmers and pharmacokinetic analysts with advanced analytical tools and regulatory expertise. Our teams work closely with project management, medical writing, clinical pharmacology, data management and monitoring specialists to support efficient communication and reliable, high-quality outcomes.
  • What statistical deliverables can sponsors expect from Nuvisan?
    Nuvisan delivers a wide range of statistical outputs, including statistical analysis plans, randomisation schemes, CDISC-compliant datasets, and tables, listings and figures for clinical study reports. We also provide pharmacokinetic and pharmacodynamic analyses, biometrical reports, as well as input for regulatory submissions and scientific manuscripts.

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Email us

hello@nuvisan.com

Talk to us

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+49 731 9840 0 

Our locations

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Neu-Ulm (headquarters)

Wegenerstrasse 13

89231 Neu-Ulm

Germany

Berlin

Muellerstrasse 178

13353 Berlin

Germany

Sophia Antipolis

2400 route des Colles

06410 Biot

France

Grafing

Am Feld 32

85567 Grafing

Germany

Waltrop

Im Wirrigen 25

45731 Waltrop

Germany

For concerns about pharmaceuticals or adverse drug-related events, contact us at: complaints@nuvisan.com
 
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