Biometrics


The statistical department provides comprehensive consulting for all biometrical aspects of your clinical trial, a phase I to IV or post-marketing NIS, an epidemiologic study or a registry. Our biostatisticians have three decades experience in clinical research and expertise in numerous therapeutic areas.

Statistical Planning

  • Elaboration of most suitable clinical trial design
  • Adaptive trial design
  • Sample size calculation and justification
  • Development of statistical sections of the protocol
  • Development of randomization schedule
  • Expert Review of trial documents
  • Development of statistical analysis plan

Analysis of data

  • Conduct of Data Review Meetings
  • Design, programming, and quality control of data displays (TLFs)
  • Confirmatory and exploratory analysis
  • Interim analysis and sample size adaption
  • Meta-Analysis and data mining

Presentation of results

  • Development of statistical reports
  • Development of statistical sections of integrated clinical study reports
  • Publications
  • Presentation of clinical Trial results
  • CDISC compilant data transfer

Additional Support

  • Consultantcy
  • Communication with regulatory authorities
  • Statistical support for Data Monitoring Board
  • Integrated summary of safety (ISS)
  • Integrated summary of efficacy (ISE)
  • Common technical document (CTD)

Our software in use

  • SAS®
  • nQuery®
  • nTerim

Your Contact

Werner Baurecht
Head of Biometrics
acromion GmbH

Europaallee 27-29
50226 Frechen

Phone: +49 (0)2234-20 37 37-17
Fax: +49 (0)2234-20 37 37-9


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