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Biostatistics & Programming

The statistical input to a study design provides a solid foundation for planning and conducting a successful clinical study.

State-of-the-art implementation and wide-ranging experience is required to ensure that the study meets the high-quality standards for regulatory purposes. Both the scientific design and methodology of the study as well as the statistical and clinical evaluation of the collected data requires strong experience. Through smart design and statistical methodology, we can optimize your study e.g. sample size, study duration, and population, to maximize results.

The Astrum biostatistics and programming team will support you at every stage of the process.

This includes:

  • Protocol writing
  • Statistical analytical planning (randomisation, sample size calculation, writing of Statistical Analysis Plan)
  • Statistical programming (incl. CDISC mapping, production of TFLs and statistical analyses), PK, PD modelling and evaluation
  • Statistical consultancy to the medical community

How can we help you?

Contact our expert team to discover how Astrum can bring value to your clinical development projects.

Other services

  • Clinical Development & Scientific Advice

    Ranging from first in human to post-marketing, Astrum’s clinical development expertise spans the entire development cycle, 
offering support every step of the way

  • Data Management

    Sponsors, investigators, and patients will receive comprehensive, 
end-to-end solutions for the collection and management of all clinical
trial data

  • Medical Writing

    We can flexibly support you from protocol to Clinical Study Report (CSR) writing. Across in-house clinical, regulatory, statistics, and medical colleagues, we’ll help achieve your study goals