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Data Management & Statistics

The statistical design is critical for the success and validity of a study, in addition to other factors. It also establishes the number of patients or test subjects.

The data is collected by means of a fully validated eCRF, which enables rapid processing at a high level of quality. However, if requested, we can also create and process classic paper CRFs, especially for multicenter studies.

proDERM's data managers and statisticians have years of experience with the special issues of dermatological trials. For standard study types, we can build on the same or similar designs from the past. Being a specialist for customized studies, the proDERM statisticians have many times mastered the challenge of new design creation for individual trials as well. Feel free to get in touch for a discussion about a possible design matching your specific needs!

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Quick Info

This is an extract of our study related services in the area of data management. Please contact us for further information.

  • CRF design, review and print
  • Data management plan
  • Data validation plan
  • Data base design and validation
  • Data capture
  • Medical Coding (i.e. MedDRA)
  • Data validation and Query management
  • Medical/scientific review
  • Support with SAE-check
  • Data listing

Our general services in the area of data management are:

  • Advice with data management
    related questions
  • Preparation of data (i.e. expert opinion)
  • Programming of VBA (MS Office)
  • Information management

This is an extract of our study related statistical services. Further information is available upon request.

  • Support with the planning of the study and
    choice of the appropriate design
  • Planning and analysing of equivalence and
    non-inferiority trials
  • Calculation of power and subject number
  • Deskriptive, explorative and
    confirmative data analysis
  • Statistical programming
  • Visual preparation and presentation
    of raw data and results
  • Preparation of a biometric report
    according to ICH/GCP requirements

These are our general statistical services:

  • Support with the generation of
    presentations and publications
  • General statistical consultancy
  • External statistical programming