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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

Patient room with white interior for clinical trials

Clinical Pharmacology Unit

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

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Doctor consulting with a patient about clinical trial recruitment

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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