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Data management

We provide data management process - complex and partial services:

  • Creation of documentation (data management plan, data validation plan) and cooperation in the creation of the study protocol
  • Ensuring data collection, integrity, completeness and reliability in accordance with FAIR principles
  • Design, creation and validation of study database for data collection (eCRF - electronic form)
  • Data cleaning, data validation, programming and setting up database controls
  • Database locking and data export for statistical processing
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We offer collection, organization, analysis, interpretation and presentation of data obtained from clinical studies - comprehensive and partial services:

  • Study design including power analysis (determination of the number of subjects needed)
  • Development of the statistical part of the protocol (synopsis) and Statistical Analysis Plan (SAP)
  • Development of Interim Analysis and DSMB
  • Development of final statistical analysis including report (ICH GCP)
  • Preparation of documents for publication of the study results in the professional press
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