Data Management & Statistics

To ensure generation of high-quality, reliable, and ready to be statistically analyzed  data, our data management unit is involved from the beginning to the completion of a clinical trial.

Key activities

  • Randomization Procedures

  • Randomization Management During Trials

  • Data Management & Plan Design

  • Data Base Set-Up

  • Production of Validation Programs

  • Validation of Database Set-Up

  • Data Entry

  • Provide Coding Dictionaries

  • Coding

  • Handling of Data Clarification Forms (DCFs)

  • Clean filing

  • (e)CRF Licenses

  • Final Data Validation

  • Transfer of Database to Sponsor

  • Statistical Analysis Plan design

  • Sample Size calculation

  • Interim Statistical Analysis

  • Final Statistical Analysis

  • Additional tables and/or listings of Subject data

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